NCT07521319

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 361 (estimated)
• Sponsor: National Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Comorbid Insomnia and Sleep Apnea (COMISA) affects approximately 30-50% of OSA patients and is associated with more severe symptoms, poorer treatment outcomes, and greater functional impairment than either condition alone. Brief Behavioral Therapy for Insomnia (BBTi) has been shown effective for insomnia management in fewer sessions than traditional CBTi. This study combines BBTi with wearable technology - a smart eye-mask integrating voice-guided relaxation, thermal massage, and physiological monitoring via an actigraphy watch - to provide an accessible, home-based intervention. Phase 1 (Specific Aim 1, 2026-2027): A mixed-methods sequential explanatory design involving (a) a cross-sectional survey (n=181) examining dysfunctional beliefs about sleep (DBAS), cognitive emotion regulation (CERQ), arousal predisposition (APS), pre-sleep arousal (PSAS), insomnia severity (ISI), and daytime sleepiness (ESS) in insomnia-only versus COMISA patients; (b) qualitative interviews (n=10-15) exploring subjective experiences; and (c) a quasi-experimental pilot (n=40) testing 4-week BBTi in COMISA (n=20) versus insomnia-only (n=20) participants. Phase 2 (Specific Aim 2, 2028): Development of the integrated smart eye-mask system with BBTi voice-guided micro-learning modules (sleep hygiene, stimulus control, sleep restriction, relaxation/breathing training, positive emotion guidance), followed by expert review and usability testing with 10 COMISA participants. Phase 3 (Specific Aim 3, 2029-2030): A multi-center, parallel-group, double-blind RCT at National Cheng Kung University Hospital and Armed Forces Kaohsiung General Hospital (802). 160 COMISA participants are randomized to four arms: (1) BBTi + smart eye-mask, (2) BBTi alone, (3) smart eye-mask alone, (4) standard sleep hygiene education (control). Assessments at baseline, 4 weeks, and 1- and 3-month follow-ups include DBAS, CERQ, APS, PSAS, ISI, ESS, sleep diary, actigraphy parameters, HRV, and CPAP adherence.

Conditions

• Comorbid Insomnia and Sleep Apnea
• Insomnia
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	Brief Behavioral Therapy for Insomnia (BBTi)	A 4-week structured behavioral sleep intervention including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training.
DEVICE	Smart Eye-Mask with Voice-Guided Modules	A wearable smart eye-mask device integrating thermal regulation (41-42C), air-pressure rhythmic eye massage (50-70 mmHg), and BBTi voice-guided micro-learning modules covering sleep hygiene, stimulus control, relaxation/breathing, body scan, and positive emotion guidance.

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-07-01
• Completion: 2030-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09