So how’s your sleep health? That increasingly common question stems from rising awareness of the extent of sleep disorders. This contributes to the development and marketing of new sleep improvement wearables says the American Academy of Sleep Medicine (AASM). According to the CDC, one out every three U.S. adults suffers from some form of sleep disorder, from insomnia to interrupted sleep. We have written about a wide range of new tech that promises to help consumers improve sleep. Most recently we wrote about Rythm‘s Dreem headband which combines multiple sleep improvement technologies. We also covered Cardiogram’s AI application used with an Apple Watch to detect sleep apnea and hypertension.
The AASM expressed four major concerns about consumer sleep technology in a position statement published in the Journal of Clinical Sleep Medicine. According to the AASM, few consumer sleep devices have been cleared by the FDA. The group also states that the lack of validated data that demonstrates the ability to accurately monitor sleep, improve sleep quality, or screen for sleep disorders raises questions about the accuracy and effectiveness of these devices. When patients present data generated from current devices, they expect that clinicians are familiar with the devices and accept the data’s accuracy. Without validation against the current gold standard polysomnography, however, clinicians cannot use the consumer device data. The last concern is that consumers with significant sleep disorders will look to untested, unvalidated consumer sleep technology rather than consult with medical professionals.
Growing consumer awareness of sleep disorders and the possibility of getting help is the silver lining in the AASM position paper. In the broader context, however, the same concerns expressed by the sleep clinician group apply to other areas of medicine. Wearable tech developers will likely face increasing pushback from the medical community without validated data and FDA clearance.