Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)
Key facts
- Where
- Tainan, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT07521319, who can take part
Where in Taiwan
- National Cheng Kung University HospitalTainan, TaiwanContact: Yen-Chin Chen, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Sun Yat-sen University
- Trial code
- NCT07521319
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
Wearable Voice-Guided Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea (COMISA): Effects on Insomnia Severity and CPAP Adherence From Mechanism Evaluation and Device Development to a Multicenter Randomized Controlled Trial
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.
Inclusion: 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: Severe chronic illness (e.g., severe heart failure or receiving hemodialysis); Severe cognitive impairment,; Major psychiatric disorder,; 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.