Group warns against using consumer devices to diagnose, treat sleep disorders

American Academy of Sleep Medicine cites lack of validation and clearance by FDA for apps and wearables.

Consumer sleep technologies, such as wearables and mobile apps, must be cleared by the Food and Drug Administration and rigorously tested if they are going to be used to diagnose or treat sleep disorders, contends the American Academy of Sleep Medicine.

Because of the lack of validation and clearance by the FDA, consumer sleep technologies “cannot be utilized for the diagnosis and/or treatment of sleep disorders at this time,” states AASM’s position statement published on Tuesday in the Journal of Clinical Sleep Medicine.

At the same time, AASM makes the case that consumer sleep technologies “may be utilized to enhance the patient-clinician interaction when presented in the context of an appropriate clinical evaluation.” Nonetheless, the professional society points out that the “ubiquitous nature” of consumer sleep technologies “may further sleep research and practice,” but “future validation, access to raw data and algorithms, and FDA oversight are needed.”

“While technology is advancing rapidly, and we are following the trends closely, consumer sleep devices currently are unable to diagnose sleep disorders,” said Ilene Rosen, MD, president of AASM. “Individuals who are dissatisfied with their sleep, experiencing an ongoing sleep problem or struggling with excessive daytime sleepiness or fatigue should discuss this important issue with a licensed medical provider, regardless of what their wearable or other consumer sleep technology device tells them.”

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In related news, a new study funded by the National Sleep Foundation and Merck—in collaboration with the Regenstrief Institute—will examine how the use of sleep tracker data might improve patient-provider communication as well as patient satisfaction.

The prospective, randomized, parallel group study of more than 200 patients with insomnia will use sleep data from Fitbit Charge 2 devices and the National Sleep Foundation’s SleepLife program—which includes an app and a portal—to provide a continuous flow of real-time sleep information that will be accessible to patients and physicians.

“The primary objective of the study is to determine if a program using a commercially available sleep tracker can be used to improve physician-patient dialogue regarding sleep,” said principal investigator Babar Khan, MD, a research scientist at the Indiana University Center for Aging Research at Regenstrief Institute and the Indiana University School of Medicine.

Ultimately, the results of the study are anticipated to serve as a model for the integration of “objective, patient-generated data” through apps and wearable technology into primary care.

“This study will provide insight into the utility of consumer sleep-monitoring devices for the incorporation of sleep as a vital sign in the primary care setting,” said Michael Paskow, director of scientific affairs and research at the National Sleep Foundation. “Delivering relevant sleep information to providers in a streamlined fashion is paramount to encouraging communication about sleep and helping people get a better night’s sleep sooner.”

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