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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in Insomnia Severity Index (ISI)_T0 [Time frame: Baseline]
• Change in Insomnia Severity Index (ISI)_T1 [Time frame: 4 weeks]
• Change in Insomnia Severity Index (ISI)_T2 [Time frame: 1 months follow-up]
• Change in Insomnia Severity Index (ISI)_T3 [Time frame: 3 months follow-up]
• Change in Arousal Predisposition Scale (APS)_T0 [Time frame: Baseline]
• Change in Arousal Predisposition Scale (APS)_T1 [Time frame: 4 weeks]
• Change in Arousal Predisposition Scale (APS)_T2 [Time frame: 1 month follow-up]
• Change in Arousal Predisposition Scale (APS)_T3 [Time frame: 3 month follow-up]
• Change in Pre-Sleep Arousal Scale (PSAS)_T0 [Time frame: Baseline]
• Change in Pre-Sleep Arousal Scale (PSAS)_T1 [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07521319 · B-ER-115-008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗