Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Feb 15, 2026
Date Accepted: Jul 25, 2026
Effectiveness of Wearable Digital Therapeutics in Improving Sleep Outcomes for Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
ABSTRACT
Background:
Wearable devices are increasingly used for sleep monitoring, yet conclusive evidence regarding their efficacy in treating adult insomnia remains limited. This meta-analysis aimed to determine whether wearable digital interventions improve sleep outcomes in adults with insomnia and to identify potential moderators of treatment effects.
Objective:
To evaluate the efficacy of wearable digital interventions on sleep outcomes compared to control conditions in adults with insomnia, and to explore potential moderators (e.g., device type, intervention duration, and geographic location) influencing treatment effects.
Methods:
We systematically searched PubMed, Web of Science, EMBASE, PsycINFO, and Cochrane databases from inception to April 30, 2025, for randomized controlled trials (RCTs) comparing wearable digital interventions against control conditions in adults with insomnia. Data extraction and quality assessment (GRADE) were performed in duplicate. Restricted Maximum Likelihood random-effects meta-analyses were conducted.
Results:
A total of 11 RCTs involving 425 participants were included. Meta-analysis revealed that wearable digital interventions were associated with a significant increase in total sleep time (Hedges’ g = 0.38, 95% CI: 0.10, 0.66) but not with improvements in Insomnia Severity Index scores (Hedges’ g = -0.29, 95% CI: -0.72, 0.14). Subgroup analyses indicated that head-mounted devices and interventions longer than one month were significantly associated with improved total sleep time. Benefits were more pronounced in East Asian populations.
Conclusions:
Wearable digital tools, particularly head-mounted devices used over extended periods, confer a small but significant improvement in objective sleep measures. However, their effect on insomnia severity is limited, and they should not replace first-line therapies like Cognitive Behavioral Therapy for Insomnia. They may serve as well-tolerated adjuncts, and future trials combining wearable biofeedback with digital CBT-I are warranted. Clinical Trial: PROSPERO CRD420251038603
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