Does changing perceptions of sleep by incorporating sleep wearables improve insomnia? Protocol for a randomized study (the Novel Insomnia Treatment Experiment).

Study objectives: Insomnia is common in the general population and is diagnosed based on self-reported sleep complaints. There is a frequent discrepancy between objectively recorded and self-reported sleep (sleep-wake state discrepancy), especially in individuals with insomnia. Although sleep-wake state discrepancy is well-documented in the literature, it is not well understood. This protocol describes the methodology of a randomized control study, which will examine whether providing monitoring and feedback about objectively recorded sleep with support for interpretation of sleep-wake state discrepancy improves insomnia symptoms and will explore the potential mechanisms of change.

Methods: Participants are 90 individuals with insomnia symptoms (Insomnia Severity Index [ISI] ≥10). Participants will be randomized to one of two conditions: (1) Intervention: feedback about objectively recorded sleep (actigraph and optional electroencephalogram headband) with guidance for data interpretation, (2) Control: sleep hygiene session. Both conditions will involve individual sessions and two check-in calls. The primary outcome is ISI score. Secondary outcomes include sleep-related impairment, symptoms of anxiety and depression, and other sleep and quality of life measures. Outcomes will be assessed using validated instruments at baseline and post-intervention.

Discussion: With increasing number of wearable devices that measure sleep, there is a need to understand how sleep data provided by these devices could be utilized in the treatment of insomnia. Findings from this study have the potential to better understand sleep-wake state discrepancy in insomnia and uncover new approaches to supplement current insomnia treatment.