Closing The Gap In Our Understanding Of Sleep Health With Fit-For-Purpose Wearable Digital Health Technologies

As digital technology continues to revolutionize society, the healthcare sector trails behind. Sleep tracking exemplifies this gap in digital transformation, signaling a call to action.

Consumer sleep tracking devices have rapidly evolved, empowering millions to monitor sleep behaviors affordably and non-invasively. Since the debut of the first Fitbit device in 2009, the popularity of sleep tracking wearables has soared. A 2023 survey by the American Academy of Sleep Medicine revealed that 35% of Americans have utilized electronic sleep-tracking devices, with 68% reporting behavioral changes based on obtained information. Consequently, personal sleep tracking devices have heightened awareness of sleep hygiene and recognition of sleep disturbances.

However, despite its profound impact in consumer settings, the integration of sleep tracking technology into clinical trials and care has been sluggish. Sleep assessments are infrequent in clinical trials, even when sleep disruption is prevalent among the target patient population. Existing assessment methods, such as polysomnography in sleep clinics or subjective reports, possess limitations.

This article delves into the current state of sleep assessments in clinical trials, advocates for a broader understanding of sleep, explores opportunities presented by wearable digital health technologies, and examines regulatory expectations. Our aim is to facilitate efficient, accurate, and meaningful evidence collection on sleep health in clinical trials, enabling medical product developers to demonstrate treatment benefits and patients to manage conditions effectively.