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
Sponsor: National Sun Yat-sen University
Trial Details
| Condition | Comorbid Insomnia and Sleep Apnea, Insomnia, Obstructive Sleep Apnea |
| Intervention | Brief Behavioral Therapy for Insomnia (BBTi); Smart Eye-Mask with Voice-Guided Modules |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 361 |
| Est. Completion | 1 July 2030 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Change in Insomnia Severity Index (ISI)_T0; Change in Insomnia Severity Index (ISI)_T1; Change in Insomnia Severity Index (ISI)_T2; Change in Insomnia Severity Index (ISI)_T3; Change in Arousal Predisposition Scale (APS)_T0; Change in Arousal Predisposition Scale (APS)_T1; Change in Arousal Predisposition Scale (APS)_T2; Change in Arousal Predisposition Scale (APS)_T3; Change in Pre-Sleep Arousal Scale (PSAS)_T0; Change in Pre-Sleep Arousal Scale (PSAS)_T1; Change in Pre-Sleep Arousal Scale (PSAS)_T2; Change in Pre-Sleep Arousal Scale (PSAS)_T3; Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0; Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1; Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2; Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3; Change in subjective sleep diary_T0; Change in subjective sleep diary_T1; Change in subjective sleep diary_T2; Change in subjective sleep parameter_T3; Change in Epworth Sleepiness Scale (ESS)_T0; Change in Epworth Sleepiness Scale (ESS)_T1; Change in Epworth Sleepiness Scale (ESS)_T2; Change in Epworth Sleepiness Scale (ESS)_T3; Change in objective sleep parameter(total sleep time)_T0; Change in objective sleep parameter(total sleep time)_T1; Change in objective sleep parameter(total sleep time)_T2; Change in objective sleep parameter(total sleep time)_T3; Change in objective sleep parameter(sleep latency)_T0; Change in objective sleep parameter(sleep latency)_T1; Change in objective sleep parameter(sleep latency)_T2; Change in objective sleep parameter(sleep latency)_T3; Change in objective sleep parameter(number of awakenings)_T0; Change in objective sleep parameter(number of awakenings)_T1; Change in objective sleep parameter(number of awakenings)_T2; Change in objective sleep parameter(number of awakenings)_T3; Change in objective sleep parameter(sleep efficiency)_T0; Change in objective sleep parameter(sleep efficiency)_T1; Change in objective sleep parameter(sleep efficiency)_T2; Change in objective sleep parameter(sleep efficiency)_T3; CPAP Adherence_T0; CPAP Adherence_T1; CPAP Adherence_T2; CPAP Adherence_T3
Eligibility Criteria
Inclusion 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.
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