Not Yet RecruitingNot Applicable

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

361 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥20 years. * Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events/hour. * Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15. * Able to understand study procedures and provide written informed consent. Exclusion Criteria: * Severe cognitive impairment, * Major psychiatric disorder, * Severe chronic illness (e.g., severe heart failure or receiving hemodialysis). * Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders). * Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months. * Pregnant or breastfeeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insomnia Severity Index (ISI)_T0

Timeframe: Baseline

Change in Insomnia Severity Index (ISI)_T1

Timeframe: 4 weeks

Change in Insomnia Severity Index (ISI)_T2

Timeframe: 1 months follow-up

Change in Insomnia Severity Index (ISI)_T3

Timeframe: 3 months follow-up

Change in Arousal Predisposition Scale (APS)_T0

Timeframe: Baseline

Change in Arousal Predisposition Scale (APS)_T1

Timeframe: 4 weeks

Change in Arousal Predisposition Scale (APS)_T2

Timeframe: 1 month follow-up

Change in Arousal Predisposition Scale (APS)_T3

Trial details

NCT IDNCT07521319

SponsorNational Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07

Contact for this trial

Yen-Chin Chen

0963412677 yenchin2427@gmail.com

View on ClinicalTrials.gov More Comorbid Insomnia and Sleep Apnea trials

Plain-language summary

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Insomnia Severity Index (ISI)_T0

Timeframe: Baseline

Change in Insomnia Severity Index (ISI)_T1

Timeframe: 4 weeks

Change in Insomnia Severity Index (ISI)_T2

Timeframe: 1 months follow-up

Change in Insomnia Severity Index (ISI)_T3

Timeframe: 3 months follow-up

Change in Arousal Predisposition Scale (APS)_T0

Timeframe: Baseline

Change in Arousal Predisposition Scale (APS)_T1

Timeframe: 4 weeks

Change in Arousal Predisposition Scale (APS)_T2

Timeframe: 1 month follow-up

Change in Arousal Predisposition Scale (APS)_T3