1 billion people suffer from OSA globally. Polysomnography (PSG), which is the gold standard investigation for diagnosing OSA, is not readily available. PSG collects only one night of data and recent studies have shown that one night of data may not be enough to establish correct severity of OSA. These facts make a case for alternate simple but accurate investigations over multiple nights for diagnosing OSA. With these facts in mind a lot of new portable devices have been recently approved by FDA for diagnosing OSA.

National Institute for Health and Care Excellence (NICE) UK have recently published their guidelines for adopting new portable devices for diagnosing OSA in NHS service. (https://www.nice.org.uk/guidance/dg62)

They have divided the patient population into 2 categories based on age-

1. Age <16yrs
2. Age 16yrs and over

They have advised to take into consideration that site where these devices have to be applied should not be hairy or hair to be removed if acceptable to the patient. Sit of application should also not have any scar or any other skin condition as these may affect the results. Results of these devices in dark skinned patients also need more validation studies.

These new devices use different technologies to diagnose OSA which are different from the signal captured by routine polygraphy or home sleep testing devices.

American Academy of Sleep Medicine (AASM) have recently given a classification for all FDA approved portable devices for diagnosing OSA. (https://doi.org/10.5664/jcsm.11290)

Note: PPG full form is photoplethysmography. PAT- Peripheral arterial tonometry

None of the PPG/PAT or Non PPG based devices are approved for use in pediatric age population except for Sleepimage which is approved in children >2yrs of age.

All of these devices can be used for multi night testing except for Breso Dx1 for which this info is not available.

All these devices use Auto-scoring which may over- or underestimate AHI depending on the AHI criteria (3% or 4%) and AHI cutoffs employed.

Almost all devices give access to raw data with the capability for manual editing of the raw data. But it may require special training to analyse the signal from these devices.

Anne Sleep

The ANNE Sleep system has been validated in clinical studies to be a reliable home sleep test for moderate and severe obstructive sleep apnea (OSA). The ANNE Sleep system has been shown to be comfortable and easy to use. 

Anne Sleep Validation studies

• ANNE Sleep vs WatchPATThe ANNE Sleep system had a positive percent agreement of 58% and a negative percent agreement of 100% compared to WatchPAT. 
• ANNE Sleep vs Alice NightOneThe ANNE Sleep system had a positive percent agreement of 85% and a negative percent agreement of 95% compared to Alice NightOne. 
• ANNE Sleep vs polysomnography (PSG)The ANNE Sleep system had a sensitivity of 90% and a specificity of 98% for diagnosing moderate or severe OSA. 

Benefits of ANNE Sleep

• Comfort: Most users found the ANNE Sleep system comfortable and easy to use. 
• Multiple nights of testing: Testing multiple nights can reclassify the severity of OSA and detect additional cases of moderate disease.

Somfit Validation studies

• Somfit vs Watch-PAT300: Somfit had an 80.92% agreement for N1/N2 sleep stages, 86.79% for NREM/REM/Wake stages, and 89.45% for sleep/wake determination compared to Watch-PAT300 
• Somfit vs PSG: Somfit had an overall percent agreement of 76.14% across five sleep stages 
• Somfit vs wearable devices: Somfit was compared to other wearable devices such as the Apple Watch, Garmin Forerunner, Polar Vantage V, and Oura Ring 

What Somfit measures? 

• Sleep stages: Somfit measures sleep stages like N1, N2, N3, REM, and wake
• Heart rate: Somfit measures heart rate and heart rate variability
• Oxygen saturation: Somfit measures oxygen saturation
• Snoring level: Somfit measures snoring level

How Somfit works?

• Somfit is a single-use adhesive-gel electrode worn on the forehead 
• The device transmits data to an app via Bluetooth 
• The app scores sleep stages and reports them to clinicians

Belun Ring

The Belun Ring is a wearable ring that uses deep learning algorithms to help diagnose sleep apnea and evaluate sleep stages. The Belun Ring has been validated through clinical studies and FDA clearance. 

Clinical studies

• Proof-of-concept studyThis study found that the Belun Ring had good accuracy in predicting obstructive sleep apnea (OSA) in people without significant health conditions or medications that affect heart rate. 
• Study on patients without significant comorbiditiesThis study found that the Belun Ring had good accuracy in predicting AHI and total sleep time. However, it tended to overestimate AHI in people with AHI under 15 events/h and underestimate AHI in people with AHI over 15 events/h. 

FDA clearance 

• The Belun Ring is FDA 510(k) cleared for diagnosing obstructive sleep apnea and sleep stages.
• The Belun Ring is FDA 510(k) cleared for home sleep apnea testing.

How it works

• The Belun Ring is a pulse oximeter that’s worn on the index finger. 
• It collects data on pulse rate, oxygen saturation, and movement. 
• The data is uploaded to the cloud, where it’s analyzed using proprietary algorithms. 
• Medical professionals can use the data to create sleep reports for patients. 

Sleepimage

SleepImage is a sleep tracking system that has been validated by clinical studies and the FDA. The SleepImage System uses auto-scoring algorithms to calculate the SleepImage Apnea Hypopnea Index (sAHI). This index is comparable to the Apnea Hypopnea Index (AHI) that is manually scored from Polysomnography (PSG) studies. 

Sleepimage Validation

• Clinical studiesStudies have shown that the SleepImage System produces comparable output to PSG studies for diagnosing sleep apnea. 
• FDA clearanceThe SleepImage System is FDA-cleared to provide comparable output to PSG studies for diagnosing sleep apnea. 

Sleepimage- How it works?

1. Patients receive a unique Patient ID and links to download the SleepImage app. 
2. Patients pair a finger-worn device with the app via Bluetooth. 
3. Patients wear the device while sleeping. 
4. Patients start and stop the test using the app. 
5. The app automatically scores the SleepImage Apnea Hypopnea Index (sAHI). 
6. Doctors can manually review and re-score the sAHI if desired.

BresoDX1

The BresoDX1 is a portable device that uses sound and motion to help diagnose moderate to severe sleep apnea in adults. The FDA granted the BresoDX1 510(k) clearance in January 2023, allowing it to be used at home. 

BresoDX1 Accuracy 

• In one study, the sensitivity of the clinical diagnosis of OSA with BresoDX was 0.89 and the specificity was 0.44 in the “best case” scenario.
• In the “worst case” scenario, the sensitivity was 0.86 and the specificity was 0.38.

BresoDX1 Strengths 

• The BresoDX1 is simple and convenient to use.
• The tracheal module is less likely to be displaced or lose signal during sleep.

Acupebble SA100

The AcuPebble SA100 is a wearable medical device that was clinically validated in a study at the NHS Royal Free Hospital in London. The study found that the AcuPebble SA100’s automated sleep apnea test results were equivalent to the gold standard for ambulatory sleep studies. 

What was the study?

• The study compared the AcuPebble SA100 to the gold standard of multi-channel polygraphy followed by manual interpretation by a sleep specialist 
• The study included 150 patients 
• The study found that the AcuPebble SA100 was diagnostically equivalent to the gold standard 

What were the results?

• The AcuPebble SA100 had a positive predictive value (PPV) of 94% and a negative predictive value (NPV) of 98% 
• 100% of patients in the study were able to complete the test without training 

What does the AcuPebble SA100 do? 

• The AcuPebble SA100 is a device that senses, records, and interprets a patient’s physiological signals during sleep
• It’s used to prescreen patients for obstructive sleep apnea (OSA)
• It can be used at home or in a clinic

Sunrise

The Sunrise sleep apnea test has been validated through clinical studies and peer-reviewed publications. The test uses machine learning to analyze mandibular movements (MM) to diagnose obstructive sleep apnea (OSA). 

Sunrise Clinical validation

• A 2022 study published in Pediatr Pulmonol found that Sunrise is accurate for diagnosing moderate-to-severe pediatric OSA 
• A study found that Sunrise’s diagnostic accuracy is comparable to respiratory polygraphy 
• A study found that Sunrise is a cost-effective alternative to home oximetry and home respiratory polygraphy 

Sunrise Peer-reviewed publications 

• A 2020 publication found that mandibular movement monitoring with machine learning analysis can diagnose sleep bruxism
• A 2021 publication found that machine learning analysis of mandibular movements can accurately detect phasic sleep bruxism in OSA patients
• A 2020 publication found that mandibular movement monitoring can detect and evaluate OSA syndrome

Sunrise-How it works?

The Sunrise test monitors mandibular movements during sleep to estimate respiratory effort. The test uses machine learning to analyze the movements to diagnose OSA. 

Device	Picture
Anne sleep
Somfit
Belun ring
Sleep image
Breso Dx1
Night owl
Accupebble
Sunrise
Wesper lab