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

Starting soon · Not applicable

Conditions studied: Comorbid Insomnia and Sleep Apnea, Insomnia, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT07521319

Run by

National Sun Yat-sen University

People needed

361

Starts

2026-08-01

Expected to finish

2030-12-01

Last updated by the study team

2026-04-09

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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