Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)
NCT: NCT07521319 · NOT_YET_RECRUITING
Brief 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.
Frequently Asked Questions
What is Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)?
Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA) is a clinical trial registered under NCT07521319. Current status: NOT_YET_RECRUITING.
What is the status of NCT07521319?
The current status of NCT07521319 (Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)) is: NOT_YET_RECRUITING.
When did Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA) start?
Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA) started on 2026-08-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.