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 often 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 randomised controlled 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 ≥ 10). Participants will be randomized to one of two conditions: (a) Intervention: feedback about objectively recorded sleep (actigraph and optional EEG headband) with guidance for data interpretation; (b) Control: sleep hygiene session. Both conditions will involve individual sessions and two check-in calls. The primary outcome is Insomnia Severity Index 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 wearable devices that measure sleep, there is a need to understand how sleep data provided by these devices could be utilised 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.