Plain language summary
Insomnia involves difficulties with initiating sleep, maintaining sleep and early morning awakenings. Sleep–wake state discrepancy is a common phenomenon observed in 9%–50% of individuals with insomnia. In fact, sleep–wake state discrepancy is important to explore as it is linked to daytime functioning, self-reported happiness, social support and self-reported sleep. The primary aim of this study was to examine whether providing individuals with insomnia feedback about sleep using wearable devices, along with support for appropriate interpretation of sleep–wake state discrepancy, improves symptoms of insomnia as the primary outcome. This study was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Eligible participants were randomised 1:1 to intervention or control groups. Results showed that the intervention group had lower insomnia symptom severity and sleep disturbance and lower rates of insomnia disorder. However, the two groups did not meaningfully differ on all other secondary and exploratory outcomes at post-intervention. Authors conclude that addressing sleep–wake state discrepancy by providing education and guidance on wearable measured sleep data could reduce symptoms of insomnia. Additionally, future studies need to examine how sleep–wake state discrepancy guidance using wearable devices could supplement cognitive behavioural therapy for insomnia (CBT-I), and whether this addition could enhance the benefits of CBT-I.
Abstract
STUDY OBJECTIVES Insomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy. METHODS A total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention. RESULTS In total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40). CONCLUSIONS Providing feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL TRIAL REGISTRATION The Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.
Methodological quality
Jadad score
:
3
Allocation concealment
:
Yes
