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Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)
Sponsor: National Sun Yat-sen University
Summary
This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants. Primary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), and CPAP adherence. The study aims to establish an evidence-based digital health intervention for improving sleep outcomes in COMISA patients.
Official title: Wearable Voice-Guided Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea (COMISA): Effects on Insomnia Severity and CPAP Adherence From Mechanism Evaluation and Device Development to a Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
361
Start Date
2026-08-01
Completion Date
2030-12
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Brief Behavioral Therapy for Insomnia (BBTi)
A 4-week structured behavioral sleep intervention including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training.
Smart Eye-Mask with Voice-Guided Modules
A wearable smart eye-mask device integrating thermal regulation (41-42C), air-pressure rhythmic eye massage (50-70 mmHg), and BBTi voice-guided micro-learning modules covering sleep hygiene, stimulus control, relaxation/breathing, body scan, and positive emotion guidance.