The American Academy of Sleep Medicine has issued a health advisory on consumer obstructive sleep apnea (OSA) self-screening smartphone applications and wearable/nearable devices.1 With and without US Food and Drug Administration (FDA) clearance, these technologies are increasingly available, marketed to the public for OSA self-screening, and coming to our clinics.
The FDA has cleared population-level OSA self-screening applications and devices using varying terms: “prescreening,” “home-screening,” and “risk assessment.”2,3 The intended use is to identify and alert high-risk users to seek clinical OSA evaluation, potentially aiding clinicians in determining the need for further diagnostic testing and evaluation. Generally trained using an apnea-hypopnea index (AHI) cutoff of ≥ 15 events/h, these applications and devices provide a device-specific, binary OSA alert, without information usually provided with diagnostic OSA testing (eg, AHI, SpO2 metrics, position, central events, sleep, raw data review). Although FDA-cleared, they often have varying sensors, insufficient transparency of dataset testing/methodologies or algorithm(s), no or few peer-reviewed performance publications, and limited details about participants with false positive or false negative results.
Unintended consequences of using these FDA-cleared technologies need consideration. People in the general population using these technologies may or may not have symptoms or OSA-associated risks. A symptomatic or clinically at-risk consumer may feel reassured by a false negative test. An asymptomatic (and without clinical risks) consumer may falsely test positive and undergo unnecessary anxiety, testing, costs, and perhaps inappropriate referral for OSA treatment. Without priority triaging, sleep centers may be overwhelmed and access to care delayed.
Having experienced atrial fibrillation screening in the general population using wearables, our cardiology colleagues have named asymptomatic wearable-screened atrial fibrillation as “subclinical atrial fibrillation” (SCAF) but have yet to determine its implications for treatment risks and benefits.4 Will subclinical OSA (SCOSA) soon emerge as a new clinical scenario in our clinics?
Until more research and guidance are available, here are some suggestions for clinicians to respond to patients who state that “my app says that I have sleep apnea”:
Inform patients that performances of self-screening and self-risk assessment technologies vary significantly. Clinicians should consider each technology for population datasets, characteristics (eg, with or without SpO2 or other data measures), high/low predictive statistics, and FDA indications (eg, inclusion/exclusions; self-screening or self-risk assessment versus diagnosis).
Conduct a comprehensive physical examination and clinical assessment of sleep habits, OSA symptoms, risk factors, and medical and medication history to offer recommendations following existing clinical guidelines.5–7
Consider whether to proceed to diagnostic testing using published clinical practice guideline recommendations and clinical judgment considering the individual circumstances presented by the patient.7
In summary, a positive result from an OSA self-screening or self-risk assessment application or device does not establish an OSA diagnosis, and further confirmatory evaluation is needed. Similarly, a negative result does not rule out OSA; at-risk patients should proceed to evaluation as clinically indicated. Interpretation of self-screening and at-risk results requires comprehensive clinical evaluation and testing prioritization. Further research in a heterogeneous population is needed to assess the risks and benefits of using consumer sleep technologies that self-screen or self-assess risk for OSA.
DISCLOSURE STATEMENT
Dr. Ambrose Chiang has received research grants from Belun Technology Company Limited and NightWare for conducting validation trials but has no other financial conflicts of interest. The other authors report no conflicts of interest.
Citation: Schutte-Rodin S, Holfinger S, Chiang AA, Bandyopadhyay A. Consumer sleep technologies that self-screen or self-assess risk for OSA: is subclinical OSA (SCOSA) coming to our clinics? J Clin Sleep Med. 2025;21(7):1325–1326.
REFERENCES
- 1. American Academy of Sleep Medicine . Health Advisory: Sleep Apps and Devices that Self-Assess Risk of Obstructive Sleep Apnea . https://aasm.org/advocacy/position-statements/sleep-apps-and-devices-that-self-assess-risk-of-obstructive-sleep-apnea . Accessed April 10, 2025.
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