Wearable, voice-guided BBTi for COMISA (insomnia + sleep apnea)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project tests a wearable, home-based approach that blends BBTi with a smart eye-mask that provides voice-guided sessions and relaxation features. The study has three phases: understanding why COMISA patients struggle with sleep, developing and testing the integrated eye-mask with BBTi content, and a multi-center randomized trial comparing the combined intervention to BBTi alone, eye-mask alone, or standard sleep hygiene. Primary outcomes include insomnia severity, daytime sleepiness, and CPAP adherence. The trial aims to establish an evidence-based digital intervention to improve sleep health in COMISA patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cheng Kung University Hospital
  Tainan, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Yen-Chin Chen
• Email: yenchin2427@gmail.com
• Phone: 0963412677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.