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

RecruitingNAAges 20 Years - 80 YearsAllNational Sun Yat-sen University
NCT07521319 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 outcom

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📋 Eligibility rules (as published)
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.
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What it tests

  • Brief Behavioral Therapy for Insomnia (BBTi)
  • Smart Eye-Mask with Voice-Guided Modules
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Where

1 site
National Cheng Kung University Hospital
Tainan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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