Health Technology Review

Portable Devices for Diagnosis of Sleep-Disordered Breathing

What Is the Issue?

• Sleep-disordered breathing (SDB) includes a range of conditions that make it difficult to breathe while sleeping and can lead to heart failure, neurodegenerative diseases, cognitive impairment, and poor quality of life. Many people in Canada have obstructive sleep apnea (OSA), a type of SDB, but they often remain undiagnosed.

• The gold standard for diagnosing SDB is polysomnography (PSG), which is referred to as a level 1 test. PSG is conducted in a sleep laboratory and attended by a sleep technician. Because access to this test can vary, is often limited geographically, and can have long wait times, portable devices for diagnosing SDB have emerged for use at home and may help speed up diagnosis and access to treatment.

• Provincial decision-makers requested this report to assess the evidence available on using portable devices for diagnosing SDB. The findings will inform whether results from these devices can be used with confidence as an alternative to PSG.

What Did We Do?

• We conducted a rapid review to identify and summarize evidence that compared the diagnostic accuracy and clinical utility of these devices as well as evidence-based guidelines published in the past 5 years. Two clinical experts reviewed the report, and 1 expert identified devices to supplement the literature available. We conducted a horizon scan to identify any new devices emerging in the field.

What Did We Find?

• A total of 92 portable sleep devices were identified. Ten systematic reviews were identified that examined the diagnostic accuracy or clinical utility of more than 60 portable diagnostic sleep tests compared to those of PSG. Five guidelines with recommendations for adults or people who are pregnant were identified, of which 1 guideline reported on 6 specific portable diagnostic sleep devices. An expert identified an additional 26 devices to consider. A Canadian guideline on the diagnosis of OSA in children was published in 2026 while this report was being written, and relevant information from that guideline has been included in this report.

• Sleep diagnostic devices have traditionally been categorized using levels. Unlike PSG studies, tests using devices categorized as level 2, 3, or 4 are unattended by a technician. Level 3 devices usually have at least 3 channels that measure airflow, respiratory effort, and oximetry. Airflow-based measurement is considered necessary to inform diagnosis. Level 4 devices usually have 1 channel measuring blood oxygen saturation and are not generally used for diagnostic purposes. Some emerging or novel devices fall outside these levels.

• Of the 92 devices identified in this report, 25 were identified as having active licensing from Health Canada and are currently being manufactured. Current evidence was identified for 6 of these devices.

• For adults suspected of having OSA, level 3 devices and some wearables (e.g., WatchPAT devices) were generally reported in systematic review evidence as having adequate sensitivity, while level 4 devices tended to have varying sensitivity and specificity. There was less evidence for other devices (e.g., noncontact systems, smartphone-based tools); generally, the evidence reported adequate sensitivity, but specificity varied by factors such as OSA severity and device type.

• For adults, guidelines recommend level 3 sleep tests for adults with a high pretest probability for moderate to severe OSA and who do not have complicated comorbidities such as chronic obstructive pulmonary disease; heart failure; neuromuscular conditions; and physical, sensory, and cognitive impairment. The AcuPebble SA100, Sunrise, WatchPAT 300, and WatchPAT ONE are 4 specific devices recommended for assessing people aged older than 16 years; the WatchPAT 300 device is licensed for sale in Canada.

• There are several evidence gaps regarding the use of portable devices for the diagnosis of SDB in specific populations. Yet, for people who are pregnant, guidelines state that home sleep apnea testing, but not overnight pulse oximetry, can be considered, and for children aged between 6 and 17 years without significant comorbidities, a Canadian guideline published in 2026 recommends PSG to diagnose OSA. It also recommends that overnight oximetry (level 4 testing) should not be used.

What Does This Mean?

• Some portable sleep devices can be considered for the diagnosis of adults suspected of having moderate to severe OSA who do not have comorbidities.

• Portable sleep devices are generally not recommended for those who have complicated comorbidities. It is also unclear whether these devices work for people of all genders and/or sexes or for people with darker skin tones given that pulse oximetry cannot accurately measure oxygen saturation in melanated skin.

• Careful consideration should be given to the following points regarding the use of portable sleep devices to diagnose SDB: the patient’s potential SDB severity and the presence of comorbidities; the number of channels the device measures; whether the device uses airflow or indirect measurements potentially generated by artificial intelligence; the accessibility and cost of the device; the security of the patient sleep data collected; whether devices and software are regularly updated or out of use; and the training or education required to support patients administering tests at home and to interpret sleep test results.

Key Terminology

Apnea-hypopnea index (AHI): A scale defined as the average number of apneas (breathing completely stops or drops to less than 10% of normal airflow for at least 10 seconds) and hypopneas (partial blockages [i.e., shallow breathing] defined as a reduction in airflow of 30% or more for at least 10 seconds) a patient experiences per hour during sleep.¹ This scale is used to diagnose and determine the severity of obstructive sleep apnea (OSA).

Equity-deserving groups: Groups of people who have historically experienced disadvantages and underrepresentation are described as equity deserving. In Canada these groups include but are not limited to Indigenous Peoples, racialized groups, women, people with disabilities, and members of 2SLGTBQ+ communities with diverse gender identities and sexual orientations.²

Gender: “Gender can refer to the individual and/or social experience of being a man, a woman, or neither. Social norms, expectations, and roles related to gender vary across time, space, culture, and individuals.”³ In cases in which the authors of included studies conducted research involving a specific sex or gender group, or in cases in which the authors reported the sex or gender of the population, findings are reported using the terms the study authors originally used.

Home sleep apnea test (HSAT): A portable device that is used to diagnose OSA and can be used outside sleep laboratory settings, such as in a patient’s home or hospital room.⁴

Obstructive sleep apnea: A sleep disorder characterized by repeated complete (apnea) or partial (hypopnea) collapses of the upper airway. This causes pauses in breathing while asleep, leading to fragmented sleep.^5,6

Person who is pregnant or people who are pregnant: These terms refer to anyone who is pregnant and are inclusive of people of all sexes and genders who may experience pregnancy.

Polysomnography (PSG): A test used to diagnose OSA that monitors breathing activity, snoring, airflow, oxygen levels, heart rate, brain activity, and muscle activity while a patient sleeps.⁷ Level 1 PSG, which is conducted in a sleep laboratory and is observed by a technologist, is considered the gold standard for diagnosing OSA. Level 2 PSG monitors the same physiologic measures as level 1 PSG but is not observed by a technologist.

PROGRESS-Plus: An acronym used to identify characteristics that stratify health opportunities and outcomes. “PROGRESS refers to place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, social capital.” Plus refers to 3 additional factors: “personal characteristics that attract discrimination (e.g., age, disability), features of relationships (e.g., smoking parents, excluded from school), and time-dependent relationships (e.g., leaving the hospital, respite care, other instances when a person may be temporarily at a disadvantage).”⁸

Sensitivity: As part of diagnostic accuracy, sensitivity is the ability of a diagnostic test to be positive for those who have the condition.⁹

Sex: The classification of people as either female, intersex, or male. Sex is typically assigned at birth based on a person’s biological traits such as reproductive systems, hormones, chromosomes, and other physical characteristics. Sex is distinct from gender identity.^3,10

Specificity: As part of diagnostic accuracy, specificity is the ability of a diagnostic test to be negative for those who do not have the condition.⁹

Research Questions

1. What is the diagnostic accuracy of portable devices for disordered breathing during sleep compared to laboratory-based PSG for people of any age?

2. What is the clinical utility of portable devices for diagnosing disordered breathing during sleep compared to PSG for people of any age?

3. What are the evidence-based guidelines regarding the use of portable devices for diagnosing disordered breathing for people of any age?

Context and Policy Issues

What Is Sleep-Disordered Breathing?

Sleep-disordered breathing (SDB) includes a spectrum of chronic conditions that can result in fragmented sleep, daytime sleepiness, reduced cognitive function, changes in respiratory airflow, apneas (i.e., breathing interruptions), heavy snoring, hypoxemia (i.e., low blood oxygen levels), brain and sympathetic nervous system activation, and fluctuations in intrathoracic pressure, blood pressure, and heart rhythms.^11-15 The International Classification of Sleep Disorders describes 4 types of SDB: central sleep apnea syndromes, OSA, sleep-related hypoventilation disorders, and sleep-related hypoxemia disorder.¹⁶

Globally, the prevalence of SDB has been estimated at 24.0% to 83.8% for men and 9.0% to 76.6% for women; for moderate to severe SDB, the estimated prevalence ranges from 7.2% to 67.2% for men and 4.0% to 50.9% for women. OSA is the most common type of SDB; it is estimated that 936 million adults aged 30 to 69 years have mild to severe OSA and 425 million have moderate to severe OSA.^17-19 Once diagnosed, patients with SDB may be treated with weight loss strategies, bariatric surgery, continuous positive airway pressure (CPAP), oral appliances, heart failure management, upper airway surgery, oxygen therapy, or phrenic nerve stimulation, among other therapeutic options.²⁰

In Canada, it is estimated that more than 900,000 people have moderate to severe OSA, more than 1 in 4 adults have a high risk for having or developing OSA, and nearly 1 in 5 adults aged older than 45 years is at risk for OSA.^17-19 Many individuals in Canada who have OSA are undiagnosed.²¹ A 2022 study of adults in Canada aged 45 years or older reported the prevalence of OSA was 17.5%, with a higher risk associated with older age, cardiovascular disease, asthma, diabetes mellitus, anxio-depressive symptoms, and arthritis.¹⁹

How Does SDB Affect People?

People with SDB or OSA may be more likely to die or to experience heart failure, stroke, neurodegenerative diseases, arrythmias, cognitive impairment, or dementia.^11,22-25 They may also be more likely to experience challenges with psychologic functioning, well-being, and social relationships.²⁶ Children may also develop OSA; however, their sleep patterns and symptoms may differ from those of adults (e.g., hyperactivity, irritability, difficulty controlling urination) and may impair their cognition, hinder emotional regulation, and lead to poor school performance.^27,28

SBD (and specifically OSA) is not a single uniform disorder but a collection of distinct clinical phenotypes (i.e., there are subgroups of patients who share common clinical presentations), physiologic endotypes (i.e., the anatomic traits that can result in OSA), and polysomnographic patterns (i.e., when during sleep OSA events occur most frequently). These subtypes help explain why patients with OSA may present differently.²⁹ These differences in the presentation of SDB, including OSA, may lead to inequities in access to treatment, especially for equity-deserving groups. There are disparities in sleep health based on gender and/or sex, culture, religion, socioeconomic status, racism, discrimination, neighbourhood segregation, and geographic regions that affect people with different work schedules, economic stresses, and challenges in accessing health care.^30-32 OSA is more prevalent in males,^19,33,34 among people in rural areas,³⁵ and among some racialized groups (e.g., Asian Americans, South Asian people).^36,37 SDB and OSA are also more prevalent in people who are in the postmenopausal stage.^19,38 A study of adults in rural Saskatchewan who did not have sleep disorder diagnoses reported individuals with the greatest distances to travel for specialist care were more likely to report OSA symptoms, suggesting decreased health care use among people who live in rural areas.³⁹ Disparities have also been reported in the prevalence of, diagnosis of, and access to treatment for OSA.^36,37,40-45 An example of a gender-based disparity is that women tend to have a greater degree of rapid eye movement (REM) related to SDB than men.⁴⁶

How Is SDB Diagnosed?

SDB is difficult to diagnose given the various symptoms that overlap with other health conditions. Sleep studies to diagnose SDB involve measuring multiple physiologic channels or signals such as breathing, snoring, brain activity, and cardiovascular measures.⁴⁷ Sleep studies have traditionally been categorized into 4 levels:^48,49

• level 1 — full PSG monitoring with at least 7 channels (i.e., electroencephalogram, electrooculogram, chin electromyography, electrocardiogram, airflow, respiratory effort, oxygen saturation), performed in a sleep laboratory with a sleep technician present who attaches sensors to a person’s body

• level 2 — a PSG with at least 7 channels that is portable and unattended (i.e., there is no overnight sleep technician present)

• level 3 — an unattended test that monitors at least 3 signals (sometimes referred to as an HSAT or portable sleep apnea testing);⁵⁰ in this report, terminology is used as reported by study authors because it is unclear whether all HSATs, level 3 devices, and devices referred to as home sleep tests are all considered the same

• level 4 — an unattended test with 1 channel, sometimes referred to simply as oximetry.

Level 1 tests are conducted in sleep laboratories.⁵¹ Level 2, level 3, and level 4 tests are unattended and can be done at home or in other nonlaboratory settings (e.g., long-term care homes, community living settings).^49,52,53 If a home sleep test has more channels, its complexity increases. This means that the data can be more difficult to capture in an unmonitored setting, and they can take longer to score and interpret by an expert.⁵⁰ Some jurisdictions, such as Alberta and British Columbia, have HSAT-accredited clinics that offer level 3 tests that are interpreted by a licensed and accredited sleep physician.^49,52,53 Level 4 tests have 1 channel and are not generally used for diagnostic purposes.^54,55

Portable HSAT devices have traditionally relied on a subset of signals used in level 1 PSG. The core measurements include photoplethysmography to derive heart rate, airflow, and respiratory effort.⁵⁴ More recently, next-generation sleep tests and devices have been developed that differ from levels 1 to 4 categorization. A framework called the Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory (SCOPER) system was issued in 2011 by the American Academy of Sleep Medicine to measure sleep, cardiovascular, oximetry, body position, effort, and respiratory parameters.^48,49

Examples of groupings of newer clinical technologies outside the levels 1 to 4 system include:

• peripheral arterial tonometry (PAT) (i.e., those that detect changes in PAT and demonstrate sympathetic nervous system activation in REM and non-REM sleep)⁴⁹

• cardiopulmonary coupling (CPC) (i.e., analysis that monitors heart rate variability and from that derives autonomic nervous system changes that can be related to obstruction in airflow);⁵⁶ this is usually coupled with other signals including oximetry, accelerometry, and gyroscopic signals.

There is also a wide variety of primarily consumer-based technologies available for potential diagnostic use, but they are not approved by scientific and clinical organizations.^57,58 These include the following categories (which are not mutually exclusive) and can be features that are part of previously mentioned devices:

• wearables (i.e., body-, finger-, or wrist-worn sensors)⁴⁹

• nearables (i.e., bed-adjacent or bed-embedded sensors)⁴⁹

• airables (i.e., video or audio recording systems)⁴⁹

• ingestibles (i.e., pills that are ingested and can monitor vital signs)^49,59,60

• morphic clothing sensors (i.e., sensors in clothing to measure airflow displacement or chest movements).^49,59,60

Another way to categorize different sleep tests considers those that are airflow-based and those that are not. Airflow-based measurement is considered essential because it measures nasal or oral airflow directly, while non–airflow-based tests use indirect signals such as PAT and blood oxygen saturation, which cannot accurately identify apnea events or differentiate between sleep apneas and hypopneas.⁶¹ Indirect methods are also known to be difficult to interpret in patients with comorbidities such as peripheral arterial disease or cardiac arrhythmias.⁶¹

In Canada, primary care physicians, nurse practitioners, specialist physicians, or dentists who suspect a patient has SDB will typically refer them to a sleep specialist for diagnosis at a sleep clinic based on specific patient criteria, although this process differs by jurisdiction.^7,39 For example, in Alberta, a primary care physician may refer a patient directly to a specialist or ask the patient to undergo testing at a community-based private clinic; most patients access home testing privately and pay out-of-pocket costs.⁶²

Why Is It Important to Do This Review?

Despite the high prevalence of SDB, and particularly of OSA, in Canada, many people experience symptoms and remain undiagnosed.²¹ While laboratory-based PSG (level 1) is considered the gold standard for diagnosing sleep apnea, there are often long wait times of several months to more than a year due to a limited number of facilities and sleep testing staff.^7,62 Home testing may also be an alternative for those suspected of having uncomplicated OSA (i.e., the absence of related comorbidities).⁶³ Many commercial devices have been developed to test sleep health that individuals can pay for privately. Due to the high number of devices in the market and the varying results these devices produce, there is a need to understand how these portable devices compare to PSG and for which populations they are most suitable.⁴⁹

The Canadian Thoracic Society published guidelines on the diagnosis and treatment of SDB in 2011, and the British Columbia Ministry of Health published guidance in 2021. While this Canada’s Drug Agency (CDA-AMC) report was being prepared, the Canadian Thoracic Society and the Canadian Sleep Society published a guideline on the diagnosis of OSA in children.⁶⁴ Previous work by CDA-AMC includes 2 recent reports: 1 published in April 2025 that describes the federal, provincial, and territorial coverage of diagnostic sleep studies (including information on public plans, funding mechanisms, costs, wait times, and patient prioritization)⁷ and 1 published in August 2023 comparing the diagnostic accuracy, clinical utility, and cost-effectiveness of at-home (level 2) versus in-clinic (level 1) PSG.⁶⁵ As previous work has been published comparing level 2 PSGs to level 1 PSGs,^65,66 we did not include these comparisons in this review.

Objectives

The objectives of this report are to identify portable sleep devices currently being used to diagnose SDB, including OSA, in Canada and to identify evidence on the diagnostic accuracy and clinical utility of these devices. The objective was not to compare portable devices, and this report does not provide formal recommendations.

We conducted a rapid review of systematic reviews (SRs) and guidelines regarding the diagnostic accuracy and clinical utility of available portable devices for diagnosing SDB, including those approved by Health Canada. To support decision-making, the evidence in this report is supplemented with information provided from 2 clinical experts. We also conducted a horizon scan to supplement the rapid review and identify emerging portable devices for diagnosing SDB.

Methods

An information specialist conducted several customized literature searches, balancing comprehensiveness with relevancy, of multiple sources and grey literature. The search for the rapid review was completed on June 3, 2025; the search for the horizon scan was completed on June 6, 2025. Supplementary searches for the horizon scan were completed on July 3 and July 8, 2025.

For the rapid review, 2 reviewers screened citations and selected studies based on the inclusion criteria presented in Table 1. They critically appraised included publications using A MeaSurement Tool to Assess systematic Reviews 2 (AMSTAR 2)⁶⁷ for SRs and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument⁶⁸ for guidelines. Because the study designs included in the rapid review were limited to SRs and guidelines, primary studies not included in the SRs may have been missed. For the horizon scan, 1 reviewer screened and selected relevant citations; these were not assessed for quality but were used to identify relevant information. Appendix 1 presents a detailed description of methods and selection criteria for included studies.

Table 1: Selection Criteria for the Rapid Review

CPAP = continuous positive airway pressure; PSG = polysomnography; QoL = quality of life; SCOPER = Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory; SDB = sleep-disordered breathing; SR = systematic review.

^aAny portable device for diagnosing SDB, including those that are classified with the level 1 to 4 system, with the SCOPER framework, as wearables, and other categories.

Findings

As of February 2026, a total of 92 portable sleep devices had been identified. Ten SRs that examined the diagnostic accuracy or clinical utility of 60 portable diagnostic sleep tests compared to PSG were identified. Five guidelines with recommendations for adults or people who are pregnant were identified, as well as 1 guideline that reported on 6 specific portable diagnostic sleep devices. An expert identified an additional 26 devices to consider.

Devices were categorized according to their method of measurement, such as the sensors they include and the physiologic signals they measure. These categories include devices based on airflow measurement, CPC, PAT, and photoplethysmography. Devices that do not fall into these categories were also included.

Table 2 presents the devices considered most relevant to decision-makers in Canada, based on the careful consideration of 1 content expert. Similar information for devices identified in the literature by rapid review is presented in Table 3, Table 4, and Table 5. The devices in this table are presented in alphabetical order, grouped by device type. For each device, we included information on whether the device includes airflow measurement, includes respiratory effort measurements using an effort belt, what its Health Canada medical device licence status is, and whether the manufacturer is active and continues to produce the device.

Table 2: Summary of Portable Sleep Diagnostic Devices

CPC = cardiopulmonary coupling; MDALL = Medical Devices Active Licence Listing; NA = not applicable; PAT = peripheral arterial tonometry; PPG = photoplethysmography.

Notes: Active indicates the device is listed in the MDALL active listing.

Discontinued indicates the device is listed as discontinued or has been replaced by a newer model on the manufacturer’s website.

Inactive indicates the device is listed in the MDALL archive listing but not in the active listing; it is no longer authorized for sale in Canada.

No match found indicates the device name was not found in MDALL.

^aWhether the device is licensed for sale in Canada as a class II medical device according to Health Canada’s MDALL.

^bWhether the manufacturer is still active.

^cWhether the manufacturer is still producing the device.

^dLegacy devices are those that are the standard of care in diagnosing SDB.

^eA more current version of the model is the ApneaLink Air.

^fThe manufacturer has 2 other devices called the Natus Embla SDx PSG Amplifier and the Embletta MPR Sleep System.

^gNot available for sale on the manufacturer’s website but available on third-party sites; a more current version of the model is the Respironics NightOne.

^hThere is an active listing for the Nox T3s System with WristOx2. Nox devices have both FDA and Health Canada clearance.^69,70

ⁱThe manufacturer lists WatchPat One and WatchPat 300 on its website. Watch PAT300 is the most current version of the device.

^jThere is a similarly named device on the manufacturer’s website called the Radius PPG Tetherless Pulse Oximetry.

Quantity of Research Available

This report includes 15 publications that met the inclusion criteria, including 10 SRs and 5 guidelines. Nine SRs^71-79 addressed question 1, while 1 SR⁸⁰ addressed question 2 and 5 evidence-based guidelines^81-85 addressed question 3. Six SRs had broader inclusion criteria than this report, including other comparators,⁷¹ other interventions (e.g., level 2 PSG)^75,79 or a broader population (e.g., people not at risk of or suspected of having sleep apnea).^77-79 Where possible, we reported on the characteristics and results from the subset of studies relevant to this report. When summarizing study characteristics, we present the totality of the evidence found and include all devices included in the SRs, such as those that are licensed for sale in Canada and still being manufactured, those licensed for sale in Canada but no longer manufactured, and those not licensed for sale in Canada and no longer manufactured.

Figure 1 in Appendix 2 presents the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA)^86,87 flow chart of the study selection.

Summary of Study Characteristics

Summaries of study characteristics are organized by research question.

Included Studies for Question 1: Diagnostic Accuracy of Portable Devices for the Diagnosis of SDB

We identified 9 SRs^71-79 that reviewed the diagnostic accuracy of 58 different portable devices (including 11 licensed for sale by Health Canada) for the diagnosis of SDB, and 7 SRs^{71-74,76,77,79} had meta-analyses. The SRs had overlap among their included primary studies; a citation matrix describing the degree of overlap between primary studies is presented in Table 25 of Appendix 6. The number of included studies within each SR ranged from 6 to 190; the included studies came from 28 countries, were published between 1986 and 2023, and included between 4 and 2,252 participants. Seven SRs^71,74-79 included participants from Canada.

Seven SRs^71-77 focused on adults (aged 18 years or older) while 2 SRs^78,79 focused on children (aged younger than 18 years). Across SRs, most of the included populations had OSA or were suspected of having OSA; fewer included populations had other types of SDB. One SR⁷⁴ had information about patients with chronic obstructive pulmonary disease (COPD) undergoing OSA evaluation.

Eight SRs^71,72,74-79 reported patient characteristic data from the studies they included, including age and proportions of female and male participants. Three SRs^74,76,78 reported male sex, 1 SR reported female sex,⁷⁴ and 4 SRs^71,72,75,79 did not indicate whether they were reporting sex or gender. None of these SRs indicated how data for female or male sex were collected. None of the included SRs reported on other PROGRESS-Plus⁸ characteristics, such as place of residence, race, ethnicity, culture, language, occupation, religion, education, socioeconomic status, or social capital.

Some SRs included a wide range of types of portable devices^75,78,79 while others focused on specific types of devices only, such as digital clinical tools (e.g., smartphones, wearables),⁷¹ facial photographs analyzed with artificial intelligence (AI),⁷² devices with PAT to measure vascular health,^76,77 noncontact devices (e.g., devices that use sound, biomotion sensors, or computer vision),⁷⁴ and wearables that analyzed data using AI.⁷¹ We identified evidence for level 3 devices,^75,78,79 level 4 devices,^75,78,79 and wearables, nearables, and airables.^71-77,79

Table 3 shows included devices for question 1 in alphabetical order and by device type (flow or nonflow), licence status, and manufacturing status; 5 devices are licensed for sale in Canada and are still currently being manufactured.

Table 3: Summary of Devices Related to Question 1

MDALL = Medical Devices Active Licence Listing.

Notes: Active indicates the device is listed in the MDALL active listing.

Discontinued indicates the device is listed as discontinued or has been replaced by a newer model on the manufacturer’s site.

Inactive indicates the device is listed in the MDALL archive listing but not in the active listing.

No information found indicates the device name was not found in MDALL.

^aLicensed for sale in Canada as a class II medical device according to Health Canada’s MDALL.

^bWhether the manufacturer is still active.

^cWhether the manufacturer is still producing the device.

^dManufacturer is now under a new name, was bought out by another company, or no longer exists.

^eThere is an active listing for the Nox T3s System with Wristox2. Nox devices have both FDA and Health Canada approval.^69,70

^fA more current version of the model is the ApneaLink Air.

^gThere are similarly named devices on the manufacturer’s website called the Radius PPG Tetherless Pulse Oximetry and Masimo Rad-G Hand-held Pulse Oximeter.

^hNot available for sale on the manufacturer’s website but available on third-party sites; a more current version of the model is the Respironics NightOne.

ⁱThe manufacturer’s website has a page mentioning these devices; however, it is unclear whether they are still available for purchase and/or still being manufactured.

^jThe device SEER 1000 is listed on the manufacturer’s website.

^kThere is an active licence for the Adult Flexiwrap Sensor Disp.

^lMDALL has an active licence for Wristox2 Pulse Oximeter.

^mThe manufacturer’s Japanese language site has the Apnomonitor 8 as the most current version of the device. The English version of the website does not list sleep apnea diagnosis devices.

ⁿThere is a newer device, EmbracePlus, that replaced the E4.

^oThe manufacturer has 2 other devices called Natus Embla SDx PSG Amplifier and the Embletta MPR Sleep System. The Embletta is no longer in use.

^pA similarly named Poly-Mesam System device was previously licensed.

^qThere is an active licence for the Digitrapper PH-Z Recorder.

^rNot available for sale on the manufacturer’s website but available on third-party sites.

^sThe manufacturer lists WatchPat One and WatchPat 300 on its website. Watch PAT300 is the most current version of the device.

The SRs reported the following diagnostic outcomes for sleep tests:

• sensitivity^71-79 (ability of the test to be positive for those with the condition)¹¹

• specificity^71-79 (ability of the test to be negative for those without the condition)¹¹

• negative predictive value^75,78 (determines true negatives)¹¹

• positive predictive value^75,78 (determines true positives)¹¹

• area under the curve^73-75,78,79 (determines how well the test can distinguish between those with and without the condition)⁸⁸

• accuracy^71,75 (the percentage of patients correctly diagnosed with the condition when using the test)

• diagnostic odds ratio^72,77 (the odds ratio of the test being positive in patients with the disease relative to the odds in patients without the disease)⁸⁹

• positive likelihood ratio^72,77 (how much more likely a positive test is found in patients with the disease compared to those without)^11,89

• negative likelihood ratio^72,77 (how much less likely a negative test is found in patients with the disease compared to those without)^11,89

• Bland-Altman analysis and Cohen’s kappa coefficient^75,77 (agreement between 2 measures; in this context, referring to agreement between results from a portable device and from PSG).^90,91

Included Studies for Question 2: Clinical Utility of Portable Devices for the Diagnosis of SDB

We identified 1 SR⁸⁰ with a meta-analysis that addressed the clinical utility of 2 portable devices (each holds an active licence from Health Canada and is currently being manufactured) for the diagnosis of SDB, which identified 3 randomized controlled trials; none had participants from Canada. The SR⁸⁰ focused on adults suspected of having OSA and provided information on participants’ ages and the proportions of male patients (it was not reported how male was defined). Participant information was not reported for other PROGRESS-Plus criteria⁸ (i.e., place of residence, race, ethnicity, culture, language, occupation, religion, education, socioeconomic status, and social capital). Different types of portable sleep monitors were used (e.g., ApneaLink Air, Embla/Embletta) as well as data from level 1 PSG; limited data were provided for analysis. Follow-up time ranged from 4 months to 6 months. Clinical outcomes of interest that the SR searched for included:

• all-cause mortality

• cardiovascular events and correlating risk factors

• CPAP usage

• quality of life (QoL)

• serious adverse events (AEs)

• sleepiness (Epworth Sleepiness Scale scores).

Table 4 shows included devices for question 2 in alphabetical order and by licence and manufacturing status; all devices are licensed for sale in Canada and are currently being manufactured.

Table 4: Summary of Devices Related to Question 2

MDALL = Medical Devices Active Licence Listing.

Note: Active indicates the device is listed in the MDALL active listing.

^aLicensed for sale in Canada as a class II medical device according to Health Canada’s MDALL.

^bWhether the manufacturer is still active.

^cWhether the manufacturer is still producing the device.

^dThe SR⁸⁰ that provided the information for this row referred to 1 device as Embla-Embletta and we retain that reporting in this table. We are aware that there are 2 separate devices, 1 called Embla and 1 called Embletta, according to the manufacturer’s website.

Included Studies for Question 3: Guidelines for the Use of Portable Devices for the Diagnosis of SDB

We identified 5 evidence-based guidelines regarding the use of 6 portable devices for the diagnosis of SDB.^81-85 Two of these devices have active Health Canada licences and are currently being manufactured. The guideline development groups were from Singapore,⁸¹ the UK,⁸³ or the US⁸² or were international.^84,85 The 2 guidelines from international groups included authors from Canada.^84,85 All identified guidelines^81-85 assessed the quality of the evidence found using various tools; details are provided in Appendix 4.

A guideline from the National Institute for Health and Care Excellence (NICE)⁸³ in the UK included guidance for adults and children; the remaining guidelines focused on guidance for adults.^81,82,84,85 The Society of Anesthesia and Sleep Medicine (SASM) and Society for Obstetric Anesthesia and Perinatology (SOAP) guideline⁸⁵ was specific to people who are pregnant. Three guidelines^81,82,84 included recommendations for people with comorbidities such as COPD, heart failure, opioid use, hypoventilation, or history of stroke.

The SASM and SOAP guideline⁸⁵ provided recommendations for people who are pregnant, recognizing that not all people who are pregnant may identify as women, while also noting limited research involving people who are pregnant who do not identify as cisgender. The NICE guideline⁸³ also considered how using these devices may affect some equity-deserving groups, including people with darker skin tones, people who have facial hair that they do not want to shave off (e.g., for religious or cultural reasons), and people who may have limited access to a smartphone or internet connection.

Table 5 shows included devices for question 3 in alphabetical order and by licence and manufacturing status; 2 devices are licensed for sale in Canada and are currently being manufactured.

Table 5: Summary of Devices Related to Question 3

MDALL = Medical Devices Active Licence Listing.

Notes: Active indicates the device is listed in the MDALL active listing.

No information found indicates the device name was not found in MDALL.

^aLicensed for sale in Canada as a class II medical device according to Health Canada’s MDALL.

^bWhether the manufacturer is still active.

^cWhether the manufacturer is still producing the device.

Summary of Critical Appraisal

Appendix 4 provides additional details about the strengths and limitations of the included publications.

Included Studies for Question 1: Diagnostic Accuracy of Portable Devices for the Diagnosis of SDB

All 9 SRs^71-79 clearly stated the populations, interventions, comparators, and outcomes of interest in sufficient detail, and the authors of 6 of these SRs^71-76 registered protocols before conducting their reviews. All SRs^71-79 included searches of at least 2 databases to find relevant studies; 2 SRs^72,77 did not include searches of additional sources (e.g., handsearches of reference lists, trial registries), so it is unclear whether their evidence had missing information. Study selection was performed in duplicate for all SRs;^71-79 however, 2 SRs^77,78 did not have data extraction conducted in duplicate and did not describe how data extraction was conducted, so it is unclear whether there may have been human error in the results reported in these SRs.

All SRs^71-79 reported the AHI thresholds the portable devices used, which indicated if devices were being used to assess mild to severe OSA, moderate to severe OSA, or severe OSA. Four SRs^74,76-78 stated data had been collected on patient sex, but none described how sex or gender had been reported. The SRs presented little information about health equity variables such as settings (e.g., urban or rural) or participants’ dimensions of diversity based on PROGRESS-Plus⁸ criteria. This made it challenging to assess how comparable the included studies were, the internal validity of the meta-analysis results, and the applicability of these results to diverse populations.

All SRs^71-79 assessed the risk of bias of individual studies with appropriate tools. One SR⁷³ used the Joanna Briggs Institute critical appraisal tool to assess diagnostic test accuracy in the studies and the other 8 SRs^71,72,74-79 used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. One SR⁷⁴ presented the sources of funding for included primary studies, but the other 8 SRs^71-73,75-79 did not; this inhibited the ability to assess the risk of sponsorship bias across the evidence.

The 7 SRs that included meta-analyses^{71-74,76,77,79} used appropriate methods to conduct and combine studies using random-effects models. However, these 7 SRs did not include sufficient investigations of the meta-analysis results, and the SRs had issues such as lack of clarity on whether heterogeneity existed or was explored further; lack of clarity on whether study quality affected results; and lack of discussion on the potential impact of heterogeneity or study quality on their findings.^{71-74,76,77,79} In addition, 6 SRs^71,74-78 discussed high heterogeneity of their evidence base, which may have been attributed to differences in study participants (e.g., age), how sleep apnea was defined and scored (i.e., cut-offs), and different devices used across studies. This made it challenging to determine whether the pooled effect estimates could be applicable to all populations or were precise enough given the variability of studies included in the meta-analyses. Most SRs^71-74,78,79 mentioned the lack of generalizability of their results to other populations or to real-world scenarios, and others^72-74,76-78 indicated there were not enough data to conduct all planned statistical analyses (e.g., sensitivity analyses, subgroup analyses).

Of the 7 SRs that included meta-analyses,^{71-74,76,77,79} 4 checked for publication bias,^72,74,77,79 of which 2 SRs^72,79 determined that the assessment indicated no effect on meta-analysis results. For the 5 SRs^{71,73,74,76,77} that showed publication bias or did not report any results for publication bias, it was unclear whether the authors missed evidence on sleep testing devices that exists but has not been published or available, and whether this affected their results.

All SR groups^71-79 reported they had no conflicts of interest; however, the authors of 3 SRs^71,74,77 did not report the funding they received to conduct their review, making it difficult to assess any potential biases. One SR⁷⁴ did not clearly report the citations and/or sources of the studies included in its review, which limited the transparency of this SR and our assessment of overlap of primary studies across all the included SRs in this report.

Included Studies for Question 2: Clinical Utility of Portable Devices for the Diagnosis of SDB

One SR⁸⁰ clearly presented its research questions and inclusion criteria and described included studies in adequate detail. A protocol was published in advance, and the review authors reported and justified their changes. The search strategy was comprehensive, and risk of bias was assessed and discussed in the results. Sources of funding of the included studies and for the review were presented so that potential biases could be assessed. While meta-analysis methods were appropriate, the pooled analyses included all studies regardless of quality, and sensitivity analyses could not be conducted because there were not enough results; it is unclear whether the pooled effect estimates presented are accurate. Data extraction was not done in duplicate, so it is unclear if there was any human error when recording quantitative information from the individual studies. Publication bias was not assessed, so it is difficult to know whether there were potentially relevant studies that could have been included in the pooled estimates but were not found in the literature search. Heterogeneity in findings was not adequately discussed, which limited a proper assessment of the final results. The SR⁸⁰ presented little information about health equity variables such as settings (e.g., urban or rural) or participants’ dimensions of diversity based on PROGRESS-Plus⁸ criteria. This made it challenging to assess how comparable the included studies were, the internal validity of the meta-analysis results, and the applicability of these results to diverse populations.

Included Studies for Question 3: Guidelines for the Use of Portable Devices for the Diagnosis of SDB

Four guideline groups^82-85 reported their objectives, health questions, and target populations and involved individuals from a range of relevant professional groups in guideline development. Two groups reported they sought views and preferences from the target population (people with suspected sleep apnea);^82,83 it was unclear if the other 2 guideline groups did this.^84,85 Three guidelines clearly defined the target users of the devices (i.e., people with suspected sleep apnea; 1 was also specific to people who are pregnant).^82,84,85

Four guideline groups^82-85 used systematic methods to search for evidence; clearly described the strengths and limitations of the evidence; considered benefits, side effects, and risks; and presented a link between the recommendations and evidence. Three guidelines presented the criteria for selecting the evidence^82,83,84 and 3 underwent external review.^82-84 One guideline⁸² provided a procedure for updating the guidance.

All 5 guidelines^81-85 clearly presented their recommendations, and 4 considered potential resource implications of using portable devices for the diagnosis of OSA.^82-85 The NICE guideline⁸³ presented facilitators and barriers to applications for implementing the use of portable devices for diagnosing OSA, and the authors stated they intended to develop tools to help implement the guidance.

Authors of the Agency for Care Effectiveness (ACE) guideline⁸¹ did not report details about their methods for creating the guideline; we referred to ACE’s methods and processes manual,⁹² which provides its core methodology for developing guidelines. We assumed these methods, which include methods for conducting a systematic search for guidelines and SRs, were followed for the development of its OSA home testing guideline. However, specific details related to how the ACE guideline was developed were unclear, including its objectives, health questions used, the involvement of external groups, the rigour of development, and applicability. This makes it difficult to determine what evidence the authors used to formulate their recommendations, how evidence is linked to their recommendations, if perspectives from all relevant professional groups and from patients were incorporated, and to whom their recommendations are applicable.

None of the guidelines reported funding sources. Two reported competing interests and how they were addressed,^82,83 1 reported competing interests but did not report how they were addressed,⁸⁵ and 2 did not report competing interests.^81,84 Without reporting of funding sources and how competing interests were addressed, it is difficult to determine if there were sources of bias in guideline development.

The NICE committee discussed a range of considerations relevant to equity-deserving groups and provided some guidance for clinicians to consider when deciding whether to use a portable device; however, their specific recommendation statements did not refer to equity-deserving groups.⁸³ The guideline by Chang et al.⁸⁴ noted differences in the prevalence of OSA by sex as well as the impact of menopause on OSA risk, but it did not provide relevant recommendations. The SASM and SOAP guideline⁸⁵ also noted the lack of studies involving people who are pregnant and are not cisgender. Thus, although their recommendations were for people who are pregnant, most of the research used to inform their guidance focused on people who are pregnant who were referred to as women.

Summary of Findings

Appendix 5 presents additional details regarding the main study findings.

Question 1: Diagnostic Accuracy of Portable Devices for the Diagnosis of SDB

Seven^71-77 of the identified SRs focused on adults (aged 18 years or older), and 2 SRs^78,79 reported on the diagnostic accuracy of portable devices for diagnosing SDB in children. We found diagnostic accuracy results for 58 devices. The diagnostic accuracy findings are summarized in Table 6. There was some overlap in the primary studies included in the SRs; the pooled estimates from separate reviews thus contain some of the same data. A citation matrix describing the degree of overlap between primary studies is presented in Table 25 of Appendix 6.

Table 6: Diagnostic Accuracy by Device Type for Adults and Children

AHI = apnea-hypopnea index; AI = artificial intelligence; APMLA = automated processing and machine learning analysis; COPD = chronic obstructive pulmonary disease; OSA = obstructive sleep apnea; PSG = polysomnography.

^aWe did not identify evidence for other comorbidities.

In the SRs for adults, most did not report if there were any differences between patient groups; only 1 relevant primary study included in 1 SR⁷³ reported on differences between female and male patients, though they did not state how sex and/or gender were defined. No other information was identified regarding whether the diagnostic accuracy of portable devices for adults may differ by any other PROGRESS-Plus⁸ criteria (i.e., place of residence, race, ethnicity, culture, language, occupation, religion, education, socioeconomic status, or social capital).

For the findings specific to adults with COPD as well as the SRs focused on children, no information was identified regarding whether the diagnostic accuracy of portable devices may differ by any PROGRESS-Plus⁸ criteria (i.e., sex or gender, place of residence, race, ethnicity, culture, language, occupation, religion, education, socioeconomic status, or social capital).

Question 2: Clinical Utility of Portable Devices for the Diagnosis of SDB

One SR with meta-analysis⁸⁰ was identified that assessed the clinical utility of portable sleep diagnostic devices compared to level 1 PSG in adults. For patients who were assessed using level 3 and level 4 devices, at a follow-up of 4 to 6 months, no statistically significant differences were identified in assessed outcomes, including sleepiness (as measured using the Epworth Sleepiness Scale), QoL, use of CPAP, or AEs (i.e., serious AEs, including cardiovascular events and correlating risk factors).

None of the included primary studies reported all-cause mortality. In addition, no information was identified regarding the clinical utility of these portable devices for the assessment of children or whether the clinical utility of these portable devices may differ by any PROGRESS-Plus⁸ criteria.

Question 3: Guidelines Regarding the Use of Portable Devices for the Diagnosis of SDB

Adults

Three guidelines^81,82,84 recommend that home testing can be used for patients who have a high pretest probability of sleep apnea. These guidelines also recommend against the use of a level 3 test or recommend a level 1 PSG over a level 3 test for patients who do not have a high pretest probability of sleep apnea. Unattended portable testing is not recommended,⁸² and a specialist trained in sleep medicine and appropriately accredited to interpret PSG data should assess the patient and review and interpret HSAT data.⁸¹ For people aged 16 years or older, the specific devices recommended to diagnose OSA hypopnea syndrome are AcuPebble SA100, Sunrise, WatchPAT 300, and WatchPAT ONE.⁸³

No guidelines had recommendations for specific equity-deserving groups. However, the NICE guideline⁸³ recommends that when deciding whether to use portable devices for diagnosing OSA hypopnea syndrome, clinicians should consider some factors that may affect the accuracy and/or usage of the device. The guideline also provides summaries of discussions about care decisions for equity-deserving groups:

• It is important to note that the diagnostic accuracy of devices that use light-based technologies such as PAT may vary with skin tone, but it is unknown if this can disadvantage or harm the health of people with darker skin tones. Clinical experts who helped develop the NICE guideline⁸³ stated that they believed these devices were unlikely to affect clinicians’ abilities to accurately diagnose sleep apnea. Overall, the guideline committee indicated that portable devices that use light-based technologies are appropriate for people with darker skin tones; however, they also highlighted it would be beneficial to have data regarding the accuracy of these devices for people with darker skin tones to determine whether any devices should be recommended over others, given that the studies reviewed for the guideline provided no evidence based on skin tone.

• Some devices attach to the neck or chin, requiring any hair in these areas to be removed for the device to attach properly. This may present an obstacle for people who have facial hair or beards who do not want to shave for a sleep study (e.g., for religious or cultural reasons). For such individuals, appropriate alternatives should be offered (e.g., a device that attaches to the finger).

• Some people have limited access to the internet, may not have smartphones that are a compatible with specific testing devices, or may not be comfortable using smartphones. These factors should be considered when deciding if home testing with a portable device is appropriate.

People With Comorbidities or Complicated Conditions

Three guidelines^81,82,84 provided recommendations related to people with comorbidities or complicated conditions. Overall, the recommendations were based on weak or low-quality evidence (e.g., observational evidence or expert opinion).

Indications for which a level 3 test was not recommended and/or a level 1 PSG was recommended instead of a level 3 test included:

• severe pulmonary, cardiovascular, or neuromuscular comorbidities,^81,82 such as:

  • COPD^81,84

  • medication-related comorbidities (e.g., those related to opioids, sedatives, hypnotics)

  • heart failure with reduced ejection fraction⁸⁴

  • potential respiratory muscle weakness caused by neuromuscular conditions⁸¹

  • awake hypoventilation or high risk for sleep-related hypoventilation⁸¹

• history of stroke^81,84

• severe sleep disruptions,⁸² such as:

  • severe insomnia⁸¹

  • sleep-related movement disorders (e.g., periodic limb movement disorder)⁸¹

  • parasomnias (e.g., REM behavioural disorder)⁸¹

  • nocturnal seizures⁸¹

  • disorders of central hypersomnolence⁸¹

  • central sleep apnea⁸²

• physical, sensory, and cognitive impairment.⁸²

Other criteria for situations in which using a level 3 test was not recommended or was considered potentially inappropriate include:

• patients using long-term home oxygen therapy⁸¹

• patients with chronic opiate medication use⁸¹

• environmental or personal factors precluding adequate data acquisition and interpretation from HSAT devices⁸¹

• patients who will not pursue therapy (e.g., those at or near the end of life)⁸²

• patients with chain of custody concerns.⁸²

One guideline⁸⁴ also explicitly recommended against using oximetry for people who:

• have heart failure with reduced ejection fraction (based on a few observational studies)

• have documented atrial fibrillation (based on case reports or expert opinion or reasoning)

• have had a stroke (based on case reports or expert opinion or reasoning).

No recommendations were provided specifically for female patients.

People Who Are Pregnant

Based on 1 guideline:⁸⁵

• HSAT devices may be used for people who are pregnant

• overnight pulse oximetry to diagnose OSA in people who are pregnant is not recommended

• repeat diagnostic testing in the postpartum period for people diagnosed with OSA during pregnancy can be considered, though the recommended timing is unknown.

Children

We did not identify guidelines that explicitly recommended or discouraged the use of portable devices for the diagnosis of SDB in children in our literature searches; however, a Canadian guideline⁶⁴ was published on this topic in 2026 while this report was being prepared. That guideline recommends that level 3 devices may be considered for the diagnosis of children aged between 6 and 17 years without significant comorbidities only if PSG is unavailable; it also recommends that overnight oximetry should not be used.⁶⁴ The 2024 NICE guideline,⁸³ which is intended for adults and children, states that more research is required involving people aged younger than 16 years.

Emerging Evidence

A horizon scan search was conducted to capture newer evidence on portable devices that were not identified via the rapid review.

Newer Devices

The articles identified in the horizon scan included information on device categories that were already covered in the rapid review, such as those that used AI, were wearables, were noncontact (i.e., nearables), used audio or video recordings, or incorporated smartphone applications or smartphone monitoring capabilities.⁴⁹ Although some specific devices identified in the horizon scan search were not the exact models identified in the SRs, they still fit into the existing categories for sleep tests and differed on technical details such as the number and type of parameters or channels measured, where the devices are placed on the body or in the sleep environment, or how they process data. For example, 1 is a fingertip-worn device that uses accelerometer and photoplethysmography sensors and linkage to an AI system to detect sleep apnea.⁹⁷ Other devices also come in different formats, such as reusable or disposable devices; disposable devices may be considered more accessible to some because they can eliminate the need to save and ship the device after use, or because they avoid hygienic contamination issues (e.g., a concern that was present during the height of the COVID-19 pandemic).^98,99

Newer categories of portable sleep devices found in the horizon scan search were sleep-omics to personalize sleep testing,¹⁰⁰ ingestible sensors, and clothing-embedded sensors.

Sleep-omics, Big Data, and Personalized Sleep Medicine

One category of sleep testing devices not found in the rapid review but identified in the horizon scan search is sleep-omics and personalized sleep medicine. Sleep medicine has relied on the AHI to determine OSA severity, but researchers and clinicians understand that sleep has complex pathways at the molecular and neuronal levels with several phenotypes; there are other symptoms outside the AHI that are important and not captured in current sleep diagnostic methods (e.g., fatigue, hormones, immunologic functions, and comorbidities).^31,100-10 People with similar AHI scores can have different physiologic symptoms and prognoses.¹⁰¹

Omics approaches simultaneously measure thousands of molecular targets at the individual level to provide personalized understandings and management of disorders rather than one-size-fits-all approaches.^31,101 More recently, omics for other clinical areas, such as food-omics for nutrition and spiro-omics for lung biology, have emerged; the overall goal is to capture information on a range of factors such genes, environment, physiology, and behaviours.¹⁰⁴ In omics approaches, big data, (i.e., large datasets) can be used to analyze several types of sleep information to provide insights on sleep neurophysiologic mechanisms, sleep disorder surveillance, sleep phenotyping, and risk prediction so that interventions can be targeted to individuals based on underlying conditions.³¹ Some studies have shown that AI data–driven models can provide more information about sleep that may not be captured in traditional diagnostic criteria such as arousal thresholds and upper airway collapsibility.¹⁰⁰ With the popularization of wearable devices that can collect large amounts of data, personalized sleep medicine may be able to help with diagnostic testing for SDB in the context of individual genetic factors, demographic characteristics, lifestyle data, and psychological information.¹⁰⁰

Ingestible Sensors

A pill that monitors patients’ vital signs has been developed to evaluate apnea events;⁴⁹ a person ingests this pill that measures real-time data from the gastrointestinal tract and wirelessly transmits heart rate and respiratory rate to create a sleep study report.⁵⁹ The pill can remain in the body for several days and is thought to overcome challenges with current diagnostic methods such as complicated physical electrodes connected to the body, costs, accuracy, and difficulty of use in unsupervised settings.⁵⁹ One trial in humans with 10 participants reported that heart rate and respiratory rate results were similar between the pill and PSG, indicating the potential of this pill to be used in sleep studies following further pill development and human trials.⁵⁹

Clothing-Embedded Sensors

Wearable morphic sensors can be embedded in clothing to measure sleep parameters such as heart rate and respiratory rate without skin contact or complicated device set-up.^49,60 These morphic sensors use the resistance of the special clothing material to gauge how the ribcage moves during respiration, and in some cases these garments are washable and reusable.^60,105 One trial with 32 participants reported that sleep measures such as respiratory rate and interbreath interval obtained from morphic sensors were accurate compared to those obtained with PSG sensors, showing that wearable morphic sensors can be a future alternative to traditional sleep tests.⁶⁰

Limitations

Generalizability

Across the 9 included SRs^71-79 that examined diagnostic accuracy, 7 had primary studies with participants in Canada;^71,74-79 because of the range of evidence from across the globe (28 countries), it is unclear how the overall findings are generalizable to people in Canada or to specific settings in Canada. The clinical utility results we found⁸⁰ were from studies of adults and did not have participants from Canada, so the generalizability to Canada is unknown, and the assessment of clinical utility in children is also unknown. This report mostly focused on populations of people with suspected OSA, so the findings may not be generalizable to populations of people who have different types of SDB. Most of the clinical evidence did not report on whether sex or gender had been documented or on the proportions of the population that were of different sexes or genders. No clinical evidence for diagnostic accuracy or clinical utility reported on other PROGRESS-Plus⁸ criteria, such as place of residence, race, ethnicity, culture, language, occupation, religion, education, socioeconomic status, or social capital; it is unclear whether the evidence found in this report is applicable to specific populations based on race, culture, or socioeconomic conditions or what the diagnostic capabilities of portable devices are in the context of various health inequities. Although 1 guideline⁸³ noted considerations for people with darker skin tones, facial hair, or lower degrees of comfort with using technologies, the specific recommendation statements were not directly related to populations with these considerations.

Some of the primary studies included in the SRs were conducted in hospital settings, and 2 SRs^71,80 noted that many included studies were conducted in hospital. It is unclear if the evidence would be different if the devices in these studies were used at home.

The target populations for the guideline recommendations included any adults,⁸¹ adults with chronic insomnia disorder or OSA,^82,84 adults with suspected OSA,⁸³ or people who are pregnant and have suspected OSA.⁸⁵ None of the guidelines we found in our literature searches were about other types of SDB or were specific to children, so the generalizability of findings of this report to younger populations is unknown. While this report was being written, a Canadian guideline⁶⁴ with recommendations for diagnosing OSA specifically in children was published; further work is needed to review and appraise this guideline.

Heterogeneity

Due to the large amount of published evidence on portable sleep diagnostic devices, there were several differences between the included SRs and the primary studies they included, which made it difficult to interpret the evidence overall. One source of heterogeneity we noted was there are more than 40 different devices reported across this evidence based on brand or device type. The SRs and guidelines also categorized the devices differently. For example, the Khor et al. (2023) study⁷⁵ grouped the ApneaLink series under level 4, while the Landry et al. (2024) study⁷⁸ categorized the ApneaLink Plus as a device that does not fit the level 3 or level 4 definitions. For this report, we presented results based on the categories the SR authors used, as they often presented pooled estimates or ranges for each category; where possible, we also tried to present findings from the same devices together.

This differential reporting and categorizing of devices present challenges when interpreting results and making meaningful inferences about whether certain devices, or certain groups of devices, have diagnostic accuracy or clinical utility. For example, devices in 1 category may differ in their accuracy due to a range of factors, such as what they are measuring, what sensors they are using, where the sensors are located, and how the data are analyzed. Our report was designed to present results by device group (i.e., level 3, level 4), and analyzing results by each device brand was beyond the scope of this report. Studies also varied in the AHI cut-offs their devices used; this may indicate that different devices are more accurate at detecting specific severities of OSA (e.g., at detecting severe OSA only, or at least moderate OSA).

The differences in device brands and types that we observed in the evidence is also corroborated by the high statistical heterogeneity across the evidence that SR authors noted: 6 SRs^71,74-78 found high heterogeneity and 4 SRs^72,73,79 did not assess heterogeneity or explore it further. The authors of 1 SR⁷⁵ did not conduct a meta-analysis because they noted the results were too different to combine into a pooled effect estimate. There was also heterogeneity among the evidence-based guidelines identified for this report. Guidelines varied in how they assessed the evidence and developed recommendations. They also varied in how they reported the strength of recommendations and the quality of evidence, which limits the ability to determine if or when a recommendation should be implemented in practice.

Evidence Gaps

We identified several evidence gaps regarding portable devices for the diagnosis of SDB for which updated summarized research may be needed, including:

• diagnostic accuracy and clinical utility:

  • for populations with forms of SDB other than OSA

  • for people with different comorbidities; several guidelines^81,82,84 recommend using portable devices for patients without specific comorbidities, often due to limited and/or low-quality studies available involving patients with comorbidities

  • in real-world settings, considering contextual factors; more research may be needed to understand how devices work in nonlaboratory settings with variables such as air quality, temperature, bedroom design, and bed materials^106,107

  • for equity-deserving groups and populations with different characteristics such as sex, gender, or other PROGRESS-PLUS⁸ criteria; it is unclear from the evidence in this report whether portable sleep testing devices have been tested in equity-deserving groups or whether they work in these populations

  • for people with darker skin tones, devices with sleep test parameters that use light-based technologies (e.g., pulse oximetry) have a known inability to accurately detect blood oxygen saturation in these populations; 1 guideline⁸³ in our report indicated that more research is needed in this area

• clinical utility:

  • for all-cause mortality

  • for children

• evidence-based guidelines for children aged younger than 2 years.

Conclusions and Implications for Decision- or Policy-Making

This report summarizes a rapid review of SRs on the diagnostic accuracy and clinical utility of portable devices for the diagnosis of SDB compared to PSG for people who have or are suspected of having SDB. We also searched for guidelines on the use of portable devices in this population. To supplement this work, we engaged 2 content experts and conducted a horizon scan to identify emerging devices. We did not compare portable devices to one another.

Summary of Evidence

As of February 2026, a total of 92 portable sleep devices for diagnosing SDB were identified. Ten SRs that examined the diagnostic accuracy or clinical utility of 60 portable diagnostic sleep tests compared to PSG were identified. Five guidelines with recommendations for adults or people who are pregnant were identified, as well as 1 guideline that reported on 6 specific portable diagnostic sleep devices. An expert identified an additional 26 devices to consider.

This report included 9 SRs^71-79 that addressed diagnostic accuracy in adults and children, 1 SR⁸⁰ that addressed clinical utility in adults, and 5 evidence-based guidelines^81-85 with recommendations for adults, people who are pregnant, and people with comorbidities such as COPD, heart failure, opioid use, hypoventilation, or history of stroke. The results from our horizon scan identified devices that were similar to those identified in the rapid review as well as emerging themes in this area (e.g., sleep-omics and personalized medicine, ingestible devices, and clothing-embedded sensors).

Based on the rapid review, there is a wide range of portable sleep devices with different diagnostic capabilities. Overall, those with a higher number of sleep measures tended to be more accurate than those with fewer parameters when compared to PSG, though this varied between studies and devices. However, most of the devices found in our rapid review of the literature from the past 5 years are not licensed in Canada and/or are no longer manufactured.

• Diagnostic accuracy

  • Overall, for adults, level 3 devices and some wearables generally have adequate sensitivity, with varying specificity depending on factors such as OSA severity and device type. Among wearable devices, WatchPAT tended to report high sensitivity, while other devices had more variable results.^71,75,77-79 Level 4 devices tended to vary more widely in their sensitivity and/or specificity.⁷⁵ Noncontact systems and other device categories (e.g., smartphone-based tools) also tended to report high sensitivity and varying specificity, but there were typically few studies for each device.^72-75,79

  • For adults with COPD, level 3 devices had moderate to high sensitivity and specificity, while level 4 devices tended to have lower sensitivities and specificities compared to results for the general population.⁷⁵ We did not identify evidence for other comorbidities.

• Clinical utility

  • One SR⁸⁰ found little to no differences between adults suspected of having OSA who were assessed using level 3 or level 4 devices and those assessed using level 1 PSG in terms of sleepiness, QoL, CPAP usage, or selected AEs. This SR did not identify any studies that assessed all-cause mortality or studies that included children.

• Guideline recommendations

  • Guidelines recommend that portable devices can be used for adults who have a high pretest probability of sleep apnea and do not have complicated conditions such as COPD, heart failure, or neuromuscular conditions.^81,82,84 HSAT devices can be used for people who are pregnant, but using pulse oximetry in this population is not recommended. One guideline⁸³ recommended 4 specific devices for people aged 16 years or older: AcuPebble SA100, Sunrise, WatchPAT 300, and WatchPAT ONE.

  • Based on information from a Canadian guideline⁶⁴ published in 2026, level 3 devices can be considered for children aged between 6 and 17 years only if PSG is unavailable; overnight oximetry should not be used.

Considerations for Future Research

Further clinical research may be needed in the following areas:

• populations with SDB conditions other than OSA (e.g., central sleep apnea syndrome)

• clinical utility of sleep diagnostic tests in adults (as only 2 device types were found for this report)

• clinical utility of sleep diagnostic tests in children (as no evidence on clinical utility was found for this population)

• clinical utility of sleep diagnostic tests on all-cause mortality outcomes for people of any age

• high-quality evidence on whether sleep diagnostic tests work in people with darker skin tones

• better-quality pooled statistical analyses given the high heterogeneity in device types.

Given the large number of different devices (each with different measurements) and the different ways to categorize devices (using levels 1 to 4, SCOPER, or airflow categories not found in this report), standardization is needed to help compare devices. Given that commercial devices are being widely used by the public, there is a need for coordination between academic researchers, patients, health professionals, and the private sector to ensure devices are valid, accurate, and can be integrated into health care. Previous studies have shown that level 3 and level 4 tests may underestimate AHI scores, which have traditionally been used to indicate the severity of sleep apnea, and they may be poor at detecting arousal, body position, seizures, REM sleep, and the difference between central and obstructive events.^4,108 Standardization may involve creating frameworks to determine which sleep variables should be recorded and how sleep data are recorded; having certification for sleep software that meets certain standards; and implementing a transparent information technology infrastructure for data.¹⁰⁹

Additional research should also consider better reporting of population information such as sex, gender, age, AHI scores, comorbidities, and PROGRSS-Plus criteria to include equity-deserving populations in research studies — and to understand whether and how sleep tests can accurately detect SDB in these populations. In this report, 1 of the 5 guidelines discussed how device accuracy may vary with skin tone,¹¹⁰ yet none of the SRs mentioned including populations with different skin tones, even though it is known that pulse oximetry is inaccurate in people with darker skin tones.^40,111 Although there are differences in OSA prevalence by sex,⁸⁴ the identified SRs did not report if they assessed differences in accuracy based on participants’ sex and/or gender. It is unclear if the devices have the same diagnostic accuracy or clinical utility for all sexes or genders. Several guidelines that we found recommend against using portable devices and/or recommended a level 1 PSG over portable devices or testing at home due to limited evidence for their use by people with comorbidities and/or complex conditions.^81,82 Conducting more research involving people with different health conditions is important because people with comorbidities can also experience sleep issues.¹¹²

The use of AI with sleep testing devices is an important consideration as more sleep testing devices are being designed to include AI functionalities. We included 2 SRs that indicated devices that use AI have at least moderate sensitivity and/or adequate accuracy for adults.⁷² Our screening identified 1 SR with a meta-analysis¹¹³ that included studies that used machine learning models to detect OSA using breathing sound recordings; however, we excluded it from this report because its included studies compared these results to HSAT results instead of to PSG. The results from this SR¹¹³ showed high sensitivities and specificities in populations with high OSA prevalence (i.e., at risk of OSA) with smartphone recordings, which did not differ by sex. However, another SR included in our review that focused on children⁷⁸ reported few studies had AI models with both high sensitivity and high specificity in this population. Taken together, this research indicates that devices that use AI may be important for diagnosis, but current models may be more accurate for adults and less accurate for children. AI models used together with sleep testing devices may improve over time, though clarity is needed regarding which models and devices are accurate and capture data securely. Further developments, including new measures and methods of analysis, may help improve the performance of newer devices. Developers and manufacturers should work to ensure the datasets used to develop and test these AI models include data from diverse populations to ensure certain groups are not underrepresented. CDA-AMC has done work in this area to highlight challenges and ethical considerations to weigh when using AI in health care.^114,115

Considerations for Policy Decision-Making

Decision-makers and health professionals may choose to use the evidence from this report to inform decisions about whether portable sleep devices can be used for people with OSA or who are suspected of having OSA. The evidence in this report from SRs indicates that portable devices are often less accurate compared to PSG, though some portable sleep devices (e.g., WatchPAT devices) appear to have adequate sensitivity for adults; accuracy may improve if devices were to measure additional sleep parameters. Guidelines recommend that portable devices can be used for adults who have a high pretest probability of having sleep apnea and do not have complex health conditions.^81-83 Level 3 devices can be considered for children aged between 6 and 17 years without significant comorbidities only if PSG is unavailable; overnight oximetry should not be used.⁶⁴

There are several considerations that decision-makers may choose to take into account, such as what sleep parameters the device is measuring (airflow or indirect methods), whether the device is still being manufactured, whether the device’s software is still updated regularly to ensure accuracy and compliance with security standards, and population characteristics (e.g., people suspected of having at least moderate OSA, those with darker skin tones, people with comorbidities). Health professionals should also consider the list of comorbid conditions that would make the use of HSAT devices inappropriate, such as COPD; heart failure; neuromuscular conditions; and physical, sensory, and cognitive impairments. The information in this rapid review can also be contextualized to Canada by using the 2025 CDA-AMC Environmental Scan of federal, provincial, and territorial coverage of sleep studies.⁷

In cases in which level 1 or level 2 PSGs are available, these testing options offer better accuracy than level 3 or level 4 sleep tests or other portable sleep testing devices because they allow for the monitoring of more physiologic measures, can help provide a more complete picture of a person’s sleep, are set up by trained technicians, and have been recommended for people with comorbidities. Attended and unattended PSGs may take up more health system resources such as clinics and equipment, staff to schedule and conduct testing, experts to analyze the results, and any additional coordination between primary care and specialists.

Funding for and access to sleep tests also vary across Canada by province or territory and by sleep test level.⁷ In cases in which PSGs are not easily available and health professionals need to use portable sleep testing device results, they should ensure they consider the risks and challenges, such as how to set up devices correctly and interpret their results, battery requirements and equipment maintenance, and privacy of sleep data.¹¹⁶ Some devices may also need to be used over multiple nights due to night-to-night variability, especially for people with mild or moderate sleep apnea; research has shown that performing at least 3 tests is ideal for diagnostic accuracy.¹¹⁷

Further considerations need to be made for devices that incorporate AI algorithms to analyze sleep data for OSA diagnoses. Many systems lack transparency about how the underlying algorithms make decisions, which makes it difficult for clinicians and patients to understand and trust their outputs.¹¹⁸ These algorithms can also perpetuate biases in multiple ways, such as if they are trained using unrepresentative data.¹¹⁹ For example, AI algorithms based on population data that exclude certain demographic groups can result in inaccurate diagnoses and misunderstanding or misrepresentation of the diversity in experiences of a health condition.¹¹⁹ This can lead to biased medical decisions, raising important concerns about equity in diagnosis.¹¹⁹ Finally, the privacy and security of patient data must be carefully considered and protected when AI platforms are used to analyze patient information.¹²⁰

Decision-makers can consider the following potential advantages portable testing devices may have over PSG:

• Portable devices may provide an option for some patients who cannot undergo a level 1 PSG (e.g., patients with physical or mental disabilities,¹²¹ children aged 6 to 17 years without significant comorbidities who do not have access to PSG).⁶⁴

• They may provide improved access to testing and convenience, which could help address long wait times in Canada.

• Portable devices may provide a more accurate real-world representation of how a patient regularly sleeps given contextual factors such as culture, familial and personal routines, at-home environment, and equipment (e.g., air quality, temperature, bed firmness), rather than in an unfamiliar laboratory setting.⁸³

It may also be helpful for health professionals to consider the needs of population groups, including equity-deserving groups, when making clinical decisions related to sleep testing.

• Sex and/or gender: OSA is more prevalent in male patients and in people in the postmenopausal stage.^19,33,34 Studies have also reported associations between hormone levels and sexual function and the severity of AHI scores that are used to assess sleep apnea.¹²² Hormonal levels of estrogen, progesterone, and testosterone can also be associated with sleep disorders, such as effects on respiratory control during the menstrual cycle,¹²² and people with OSA can be at risk of metabolic and endocrinal disorders.¹²³ These are important considerations for members of 2SLGBTQ+ communities and/or for those who may be taking hormones for hormone therapy or gender-affirming care.¹²⁴

• People living in rural or remote areas or those with accessibility challenges: People in Canada who live in rural or remote communities often face longer wait times for OSA diagnosis compared to people living in urban centres.¹²⁵ These people and those with accessibility challenges must consider the time, effort, and costs of travel (e.g., overnight accommodations).⁶² This may make it difficult for them to access diagnostic services and can lead to delays in treatment and worsened health.

• Differences affecting racial and/or ethnic groups:

  • In the US, Black people with OSA tend to experience more severe apnea, have higher subjective sleepiness, use CPAP treatments less, and may not be diagnosed or treated until their disease severity is greater. This may in part be due to less screening of and fewer referrals for these individuals in primary care settings, overlap of their symptoms with other conditions, cultural factors (e.g., distrust in the medical system), and diagnostic testing devices being designed for people with lighter skin.^40,41 These devices are inaccurate in people with darker skin; for example, light-based technologies such as pulse oximetry, produce inaccurate results for people with darker skin, which can lead to the underdiagnosis of OSA and missed treatment opportunities.^40,111 Photoplethysmography, which pulse oximetry is based on, emits infrared light into a person’s skin, and the absorption of light is supposed to indicate oxygen saturation; however, in people with more melanin, the light is transmitted differently and affects oxygen saturation readings.¹²⁶

  • Research has also indicated a high prevalence of OSA and poorer sleep quality among Asian adults.^36,42 Studies have reported that compared to white adults, Chinese and Hispanic adults experience a higher prevalence of SDB,⁴³ and South Asian adults may experience higher prevalence and worse severity of OSA.³⁷ This may be because of difficulties with how sleep is reported⁴⁴ or how physicians ask certain populations about sleep issues;⁴⁵ this may contribute to underdiagnosis in this population.

Acknowledgements

We would like to thank the content experts who externally reviewed this document and granted permission to be acknowledged.

Alan GD Hoffman, MD, PhD, FRC PC, FCCP

Assistant Clinical Professor, Department of Medicine

University of British Columbia, Vancouver Island

Dr. Hoffman disclosed no conflicts of interest.

Mandeep Singh, MBBS MD MSc FRCPC

Associate Professor

Department of Anesthesiology and Pain Management, University of Toronto

Dr. Singh disclosed no conflicts of interest.

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Appendix 1: Detailed Methods and Selection of Included Studies for Rapid Review

Please note that this appendix has not been copy-edited.

What Is a Rapid Review?

Rapid reviews are based on accelerated and abbreviated SR methods, balancing timeliness with rigour, to allow for timely decision-making. Due to these abbreviated methods, rapid reviews have some limitations. For example, we included studies published from 2020, excluding older studies. We attempted to mitigate this by searching for and including relevant SRs published in the past 5 years that included older studies. Focusing on more recently published articles may also be more reflective of current practices.

Literature Search Methods

An information specialist conducted a literature search on key resources including MEDLINE, Embase, the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of health technology assessment agencies in Canada and major international health technology assessment agencies, as well as a focused internet search. The search approach was customized to retrieve a limited set of results, balancing comprehensiveness with relevance. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. The main search concepts were home-based or portable diagnostic devices and sleep-disordered breathing. Search filters were applied to limit retrieval to health technology assessments, SRs, meta-analyses, or indirect treatment comparisons, guidelines, any types of clinical trials or observational studies, conference reviews, and conference abstracts. Supplementary searches were conducted for nonsystematic reviews and regulatory information and advisories related to specific devices.

The initial searches were completed on June 3 and June 6, 2025, for English-language documents published since January 1, 2020. The supplementary searches were completed on July 3 and July 8, 2025. The search strategies are available on request.

Selection Criteria and Methods

Two reviewers screened citations and selected studies using Covidence software (www.covidence.org). In the first level of screening, they independently screened titles and abstracts of all retrieved citations for relevance whereby a single reviewer was required to include or exclude a study. Full texts of titles and abstracts that were judged to be potentially relevant by 1 reviewer were retrieved and independently assessed by 2 reviewers for inclusion based on the inclusion criteria presented in Table 1. Discrepancies between reviewers at the full-text level were discussed until consensus was reached. Figure 1 in Appendix 2 presents the PRISMA flow chart of the study selection.

Exclusion Criteria

Articles were excluded if they:

• did not meet the selection criteria outlined in Table 1

• were duplicate publications

• were SRs in which all relevant studies were captured in other more recent or more comprehensive systematic reviews

• were guidelines with unclear methodology

• were comparing level 2 to level 1 sleep tests

• had results only for a mixed population including “healthy” individuals

• had results for a population already represented in an included SR.

Critical Appraisal of Individual Studies

The included publications were critically appraised by 1 reviewer using the following tools as a guide: AMSTAR 2⁶⁷ for SRs and the AGREE II instrument⁶⁸ for guidelines. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.

Data Extraction

One reviewer extracted data directly into standardized tables created in Microsoft Word, which were modified as necessary. The extracted information included study characteristics, methodology (e.g., study design), population, intervention, comparator, and results for outcomes of interest that were compared to Level 1 PSG.

One reviewer extracted information from the included studies using the PROGRESS-Plus⁸ tool to describe different population groups. Each included study was checked to determine if PROGRESS-Plus⁸ criteria were reported by study authors to describe the participants; detailed characteristics, if available, were then extracted and reported in tables in Appendix 3. The main PROGRESS-Plus⁸ criteria include place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital. As part of report writing, we discuss these characteristics across the evidence, where available, when presenting results within the text.

When reporting on sex, gender, race, or ethnicity we planned to retain the language used by the original study authors, and, whenever possible, we referred to these groups based on guidance from the CDA-AMC Style Guide¹²⁷ at the time this report was conducted, with an understanding that language is constantly evolving.

External Review

This report was externally reviewed by 2 content experts. One expert reviewed devices found in the literature and provided additional information on the following features: airflow, CPC, PAT, photoplethysmography, and whether the devices have been used in Canada for years or are newer devices. The expert also provided additional information on HSAT devices that were not captured in our literature search. These were incorporated into this report.

Appendix 2: Selection of Included Studies for the Rapid Review

Please note that this appendix has not been copy-edited.

Figure 1: PRISMA Flow Chart of the Selection of Included Studies

PRISMA = Preferred Reporting Items for Systematic reviews and Meta-Analyses.

Appendix 3: Characteristics of Included Publications

Please note that this appendix has not been copy-edited.

Table 7: Characteristics of Included Systematic Reviews — Diagnostic Accuracy

AHI = apnea-hypopnea index; AUC = area under the curve; CPAP = continuous positive airway pressure usage; HSAT = home sleep apnea test; NA = not applicable; NPV = negative predictive value; NR = not reported; PAT = peripheral arterial tonometry; PPV = positive predictive value; PSG = polysomnography; RCT = randomized controlled trial; SD = standard deviation; SR = systematic review.

^a“Sex/gender” indicates that that study did not indicate if they were reporting sex or gender, while “sex” indicates the review authors stated they were reporting on sex. None of the studies indicated how sex or gender data were collected.

^bDevice is licensed for sale by Health Canada.

Table 8: Characteristics of Included Systematic Review — Clinical Utility

AE = adverse event; AHI = apnea-hypopnea index; CPAP = continuous positive airway pressure usage; NR = not reported; PSG = polysomnography; QoL = quality of life; RCT = randomized controlled trial.

^aDevice is licensed for sale by Health Canada.

Table 9: Characteristics of Included Guidelines

AAP SCQIM = American Academy of Pediatrics Steering Committee on Quality Improvement and Management; ACC = American College of Cardiology; ACE = Agency for Care Effectiveness; AGREE II = Appraisal of Guidelines for Research and Evaluation II; AHA = American Heart Association; AHI = apnea-hypopnea index; DoD = Department of Defense; EBP = evidence-based practice; GRADE = Grading of Recommendations Assessment, Development and Evaluation; HRQoL = health-related quality of life; LOE = level of evidence; NICE = National Institute for Health and Care Excellence; NR = not reported; NRS = nonrandomized studies; OSA = obstructive sleep apnea; QUADAS-2 = Quality Assessment of Diagnostic Accuracy Studies; RDI = respiratory disturbance index; SASM = Society of Anesthesia and Sleep Medicine; SOAP = Society of Anesthesia and Sleep Medicine and the Society for Obstetric Anesthesia and Perinatology; SR = systematic review; USPSTF = US Preventive Services Task Force; VA = Veterans Affairs.

^aDetailed methods for this specific guideline were not provided; information about the methods were based on a separate general methods and process document,⁹⁰ which was assumed to apply to all guidelines produced by this agency.

Appendix 4: Critical Appraisal of Included Publications

Please note that this appendix has not been copy-edited.

Table 10: Diagnostic Accuracy of Portable Devices for Diagnosis of Sleep-Disordered Breathing — Strengths and Limitations of Systematic Reviews Using AMSTAR 2⁶⁷

AI = artificial intelligence; AMSTAR 2 = A MeaSurement Tool to Assess systematic Reviews 2; AUC = area under the curve; NR = not reported; OSA = obstructive sleep apnea; QUADAS-2 = Quality Assessment of Diagnostic Accuracy Studies; SR = systematic review.

Note: Information about how SRs were funded was based on what was reported in included articles; we did not consult systematic review authors to request funding details.

Table 11: Clinical Utility of Portable Devices for Diagnosis of Sleep-Disordered Breathing — Strengths and Limitations of Systematic Reviews Using AMSTAR 2⁶⁷

AMSTAR 2 = A MeaSurement Tool to Assess systematic Reviews 2; NR = not reported; PSG = polysomnography; RoB = risk of bias; RCT = randomized controlled trial; SR = systematic review.

Note: Information about how SRs were funded was based on what was reported in included articles; we did not consult systematic review authors to request funding details.

Table 12: Evidence-Based Guidelines for Portable Devices for Diagnosis of Sleep-Disordered Breathing — Strengths and Limitations of Guidelines Using AGREE II⁶⁸

ACE = Agency for Care Effectiveness; AGREE II = Appraisal of Guidelines for Research and Evaluation II; DoD = Department of Defense; NA = not applicable; NICE = National Institute for Care Excellence; NR = not reported; SASM = Society of Anesthesia and Sleep Medicine; SOAP = Society for Obstetric Anesthesia and Perinatology; VA = Veterans Affairs.

Note: Information about how systematic reviews were funded was based on what was reported in included articles; we did not consult systematic review authors to request funding details.

^aWe retained the domain names that are included in the original AGREE II checklist, which includes the term stakeholder (i.e., in Domain 2), to be clear that we assessed the strengths and limitations of guidelines using AGREE II. However, the CDA-AMC understands that language is constantly evolving and the word stakeholder has association with colonialism; whenever possible, CDA-AMC does not use this word in our reports.

^bBased on general methods and processes manual.⁹²

^cGuideline authors state in the document’s implementation section, “NICE intends to develop tools, in association with relevant stakeholders, to help organisations put this guidance into practice.”⁸³ It is unclear if these tools are in development or have been developed.

^dRecommendations provided related to re-testing.

^eFunding was not reported.

^fCompeting interests reported; unclear how they were addressed.

Appendix 5: Main Study Findings

Please note that this appendix has not been copy-edited.

Table 13: Summary of Findings by Outcome in Adults — Sensitivity, Specificity, and AUC