The Circadian Rhythm for Sleep digital therapeutic for insomnia: Conceptual background and single-arm feasibility study

초록

Objective: To assess the feasibility, acceptability, and preliminary effects of circadian rhythm for sleep (CRS), a mobile digital therapeutic that delivers closed-loop, wearable- and light-sensor-driven circadian coaching for insomnia. Methods: Six-week, single-arm feasibility study in adults with short-term or chronic insomnia. CRS provided daily recommendations emphasizing stable wake-up time, morning light exposure, and daytime activity. Feasibility and acceptability outcomes were assessed (completion, passive-sensor data capture/adherence, satisfaction), and the primary clinical outcome (exploratory) was change in Insomnia Severity Index (ISI) from baseline to Week 6; the key secondary clinical outcome (exploratory) was Pittsburgh Sleep Quality Index (PSQI). Objective sleep-wake metrics from wearable device were explored. Results: Twenty-three participants were enrolled; 20 completed the program (87.0%), and 16 comprised the prespecified analysis set based on data-fidelity criteria. Among these 16 participants, valid passive sensor data from the wearable and light sensors were captured on 88.6% of study days. ISI significantly improved from baseline to Week 6 (median 21.0 -> 14.0; p < .001 by within-subject analysis), and PSQI improved (mean 10.9 -> 7.7; p < .001; partial eta(2) approximate to 0.50). Objective wearable metrics (total sleep time, time-in-bed, sleep onset, wake time) did not change significantly over time in this short pilot. Satisfaction was favorable (mean 37.9/45). No adverse events occurred. Conclusions: CRS was feasible and acceptable, and was associated with within-subject improvements in subjective insomnia symptoms in this single-arm feasibility study; however, because there was no control group, these findings are preliminary and hypothesis-generating, supporting further evaluation in larger randomized controlled trials. Trial registry name: Clinical Research Information Service URL: https://cris.nih.go.kr Trial registration number: KCT0010801

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