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.
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Change in Insomnia Severity Index (ISI)_T0
Timeframe: Baseline
Change in Insomnia Severity Index (ISI)_T1
Timeframe: 4 weeks
Change in Insomnia Severity Index (ISI)_T2
Timeframe: 1 months follow-up
Change in Insomnia Severity Index (ISI)_T3
Timeframe: 3 months follow-up
Change in Arousal Predisposition Scale (APS)_T0
Timeframe: Baseline
Change in Arousal Predisposition Scale (APS)_T1
Timeframe: 4 weeks
Change in Arousal Predisposition Scale (APS)_T2
Timeframe: 1 month follow-up
Change in Arousal Predisposition Scale (APS)_T3
Timeframe: 3 month follow-up
Change in Pre-Sleep Arousal Scale (PSAS)_T0
Timeframe: Baseline
Change in Pre-Sleep Arousal Scale (PSAS)_T1
Timeframe: 4 weeks
Change in Pre-Sleep Arousal Scale (PSAS)_T2
Timeframe: 1 month follow-up
Change in Pre-Sleep Arousal Scale (PSAS)_T3
Timeframe: 3 month follow-up
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0
Timeframe: Baseline
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1
Timeframe: 4 weeks
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2
Timeframe: 1 month follow-up
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3
Timeframe: 3 month follow-up
Change in subjective sleep diary_T0
Timeframe: Baseline
Change in subjective sleep diary_T1
Timeframe: 4 weeks
Change in subjective sleep diary_T2
Timeframe: 1 month follow-up
Change in subjective sleep parameter_T3
Timeframe: 3 month follow-up
Change in Epworth Sleepiness Scale (ESS)_T0
Timeframe: Baseline
Change in Epworth Sleepiness Scale (ESS)_T1
Timeframe: 4 weeks
Change in Epworth Sleepiness Scale (ESS)_T2
Timeframe: 1 month follow-up
Change in Epworth Sleepiness Scale (ESS)_T3
Timeframe: 3 months follow-up
Change in objective sleep parameter(total sleep time)_T0
Timeframe: Baseline
Change in objective sleep parameter(total sleep time)_T1
Timeframe: 4 weeks
Change in objective sleep parameter(total sleep time)_T2
Timeframe: 1 months follow-up
Change in objective sleep parameter(total sleep time)_T3
Timeframe: 3 months follow-up
Change in objective sleep parameter(sleep latency)_T0
Timeframe: Baseline
Change in objective sleep parameter(sleep latency)_T1
Timeframe: 4 weeks
Change in objective sleep parameter(sleep latency)_T2
Timeframe: 1 month follow-up
Change in objective sleep parameter(sleep latency)_T3
Timeframe: 3 month follow-up
Change in objective sleep parameter(number of awakenings)_T0
Timeframe: Baseline
Change in objective sleep parameter(number of awakenings)_T1
Timeframe: 4 weeks
Change in objective sleep parameter(number of awakenings)_T2
Timeframe: 1 month follow-up
Change in objective sleep parameter(number of awakenings)_T3
Timeframe: 3 month follow-up
Change in objective sleep parameter(sleep efficiency)_T0
Timeframe: Baseline
Change in objective sleep parameter(sleep efficiency)_T1
Timeframe: 4 weeks
Change in objective sleep parameter(sleep efficiency)_T2
Timeframe: 1 month follow-up
Change in objective sleep parameter(sleep efficiency)_T3
Timeframe: 3 month follow-up
CPAP Adherence_T0
Timeframe: Baseline
CPAP Adherence_T1
Timeframe: 4 weeks
CPAP Adherence_T2
Timeframe: 1 month follow-up
CPAP Adherence_T3
Timeframe: 3 month follow-up