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

Abstract

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.