Consumer sleep technology must be cleared by the Food and Drug Administration (FDA) and rigorously tested if it is intended to diagnose or treat sleep disorders, says a position statement from the American Academy of Sleep Medicine (AASM). The position statement is published in Journal of Clinical Sleep Medicine.
Consumer sleep technologies are non-prescription devices such as wearables and mobile apps that are directly marketed to consumers to monitor sleep, improve sleep quality, or screen for sleep disorders. However, there are minimal data validating the ability of these devices to accurately perform these functions, and to date almost no consumer sleep devices have undergone review by the FDA.
The lack of validation data and absence of FDA clearance raises concerns about the accuracy of consumer sleep technology. Therefore, it is important for health care providers to understand the capabilities and limitations of these devices.
As the popularity of consumer sleep technology continues to grow, clinicians are increasingly asked to analyze patient-generated health data. However, health care providers must recognize that this data should be considered in the context of a comprehensive sleep evaluation and should not replace validated diagnostic testing.
"While technology is advancing rapidly, and we are following the trends closely, consumer sleep devices currently are unable to diagnose sleep disorders," said AASM President Dr. Ilene Rosen. "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."
Despite their limitations, consumer sleep devices may increase awareness of the importance of sleep and the potential presence of a sleep disorder. Therefore, this technology can promote meaningful interactions between patients and clinicians when discussed during an appropriate clinical evaluation.
"I, like many of my colleagues, have seen more patients presenting to the sleep clinic to discuss their abnormal data," said Khosla. "They are looking for ways to improve their sleep and reaching out to their local sleep specialists for guidance. I believe consumer sleep technology allows us to partner with our patients to improve their sleep."