Clinical Trial

Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)

Study acronym: BBTi-COMISA
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07521319
Lead Sponsor National Sun Yat-sen University
Conditions Comorbid Insomnia and Sleep Apnea, Insomnia, Obstructive Sleep Apnea
Enrollment 361 participants
Start Date 2026-08-01
Primary Completion 2030-07 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-09