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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 361
- 主要终点
- Change in Insomnia Severity Index (ISI)_T0
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Able to understand study procedures and provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
BBTi + Smart Eye-Mask
Participants receive 4-week Brief Behavioral Therapy for Insomnia (BBTi) at clinic plus nightly use of smart eye-mask with voice-guided BBTi modules at home for 15-20 minutes.
干预措施: Brief Behavioral Therapy for Insomnia (BBTi) (Behavioral)
BBTi + Smart Eye-Mask
Participants receive 4-week Brief Behavioral Therapy for Insomnia (BBTi) at clinic plus nightly use of smart eye-mask with voice-guided BBTi modules at home for 15-20 minutes.
干预措施: Smart Eye-Mask with Voice-Guided Modules (Device)
BBTi Alone
Participants receive 4-week Brief Behavioral Therapy for Insomnia (BBTi) including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training.
干预措施: Brief Behavioral Therapy for Insomnia (BBTi) (Behavioral)
Smart Eye-Mask Alone
Participants use smart eye-mask with voice-guided modules nightly for 4 weeks without structured BBTi intervention.
干预措施: Smart Eye-Mask with Voice-Guided Modules (Device)
Standard Sleep Hygiene Education
Participants receive standard sleep hygiene education materials only.
结局指标
主要结局
Change in Insomnia Severity Index (ISI)_T0
时间窗: Baseline
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Change in Insomnia Severity Index (ISI)_T1
时间窗: 4 weeks
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Change in Insomnia Severity Index (ISI)_T2
时间窗: 1 months follow-up
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Change in Insomnia Severity Index (ISI)_T3
时间窗: 3 months follow-up
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Change in Arousal Predisposition Scale (APS)_T0
时间窗: Baseline
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Change in Arousal Predisposition Scale (APS)_T1
时间窗: 4 weeks
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Change in Arousal Predisposition Scale (APS)_T2
时间窗: 1 month follow-up
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Change in Arousal Predisposition Scale (APS)_T3
时间窗: 3 month follow-up
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Change in Pre-Sleep Arousal Scale (PSAS)_T0
时间窗: Baseline
Change in pre-sleep arousal measured by the PSAS, an 16-item self-report questionnaire scored 16-80, with higher scores indicating higher pre-sleep arousal.
Change in Pre-Sleep Arousal Scale (PSAS)_T1
时间窗: 4 weeks
Change in pre-sleep arousal measured by the PSAS, an 16-item self-report questionnaire scored 16-80, with higher scores indicating higher pre-sleep arousal.
Change in Pre-Sleep Arousal Scale (PSAS)_T2
时间窗: 1 month follow-up
Change in pre-sleep arousal measured by the PSAS, an 16-item self-report questionnaire scored 16-80, with higher scores indicating higher pre-sleep arousal.
Change in Pre-Sleep Arousal Scale (PSAS)_T3
时间窗: 3 month follow-up
Change in pre-sleep arousal measured by the PSAS, an 16-item self-report questionnaire scored 16-80, with higher scores indicating higher pre-sleep arousal.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0
时间窗: Baseline
Change in cognitive emotion regulation measured by the CERQ, a 36-item self-report measure assessing nine cognitive emotion regulation strategies (four items per strategy). Items are rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing item scores; higher subscale scores indicate more frequent use of the corresponding strategy.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1
时间窗: 4 weeks
Change in cognitive emotion regulation measured by the CERQ, a 36-item self-report measure assessing nine cognitive emotion regulation strategies (four items per strategy). Items are rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing item scores; higher subscale scores indicate more frequent use of the corresponding strategy.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2
时间窗: 1 month follow-up
Change in cognitive emotion regulation measured by the CERQ, a 36-item self-report measure assessing nine cognitive emotion regulation strategies (four items per strategy). Items are rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing item scores; higher subscale scores indicate more frequent use of the corresponding strategy.
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3
时间窗: 3 month follow-up
Change in cognitive emotion regulation measured by the CERQ, a 36-item self-report measure assessing nine cognitive emotion regulation strategies (four items per strategy). Items are rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing item scores; higher subscale scores indicate more frequent use of the corresponding strategy.
Change in subjective sleep diary_T0
时间窗: Baseline
Change in subjective sleep quality measured by the self-report sleep diary. Participants will complete a daily sleep diary to assess subjective sleep. Recorded items include bedtime, sleep onset time, number of awakenings, final awakening time, time out of bed, and self-rated sleep quality (1-10, with higher scores indicating better sleep quality).
Change in Epworth Sleepiness Scale (ESS)_T2
时间窗: 1 month follow-up
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Change in subjective sleep diary_T1
时间窗: 4 weeks
Change in subjective sleep quality measured by the self-report sleep diary. Participants will complete a daily sleep diary to assess subjective sleep. Recorded items include bedtime, sleep onset time, number of awakenings, final awakening time, time out of bed, and self-rated sleep quality (1-10, with higher scores indicating better sleep quality).
Change in subjective sleep diary_T2
时间窗: 1 month follow-up
Change in subjective sleep quality measured by the self-report sleep diary. Participants will complete a daily sleep diary to assess subjective sleep. Recorded items include bedtime, sleep onset time, number of awakenings, final awakening time, time out of bed, and self-rated sleep quality (1-10, with higher scores indicating better sleep quality).
Change in subjective sleep parameter_T3
时间窗: 3 month follow-up
Change in subjective sleep parameter measured by the self-report sleep diary. Participants will complete a daily sleep diary to assess subjective sleep. Recorded items include bedtime, sleep onset time, number of awakenings, final awakening time, time out of bed, and self-rated sleep quality (1-10, with higher scores indicating better sleep quality).
Change in Epworth Sleepiness Scale (ESS)_T0
时间窗: Baseline
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Change in Epworth Sleepiness Scale (ESS)_T1
时间窗: 4 weeks
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Change in Epworth Sleepiness Scale (ESS)_T3
时间窗: 3 months follow-up
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Change in objective sleep parameter(total sleep time)_T0
时间窗: Baseline
Change in objective sleep parameters measured by actigraphy. Total sleep time (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(total sleep time)_T1
时间窗: 4 weeks
Change in objective sleep parameters measured by actigraphy. Total sleep time (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(total sleep time)_T2
时间窗: 1 months follow-up
Change in objective sleep parameters measured by actigraphy. Total sleep time (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(total sleep time)_T3
时间窗: 3 months follow-up
Change in objective sleep parameters measured by actigraphy. Total sleep time (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep latency)_T0
时间窗: Baseline
Change in objective sleep parameters measured by actigraphy. Sleep latency (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep latency)_T1
时间窗: 4 weeks
Change in objective sleep parameters measured by actigraphy. Sleep latency (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep latency)_T2
时间窗: 1 month follow-up
Change in objective sleep parameters measured by actigraphy. Sleep latency (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep latency)_T3
时间窗: 3 month follow-up
Change in objective sleep parameters measured by actigraphy. Sleep latency (minutes) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(number of awakenings)_T0
时间窗: Baseline
Change in objective sleep parameters measured by actigraphy. Number of awakenings (counts) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(number of awakenings)_T1
时间窗: 4 weeks
Change in objective sleep parameters measured by actigraphy. Number of awakenings (counts) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(number of awakenings)_T2
时间窗: 1 month follow-up
Change in objective sleep parameters measured by actigraphy. Number of awakenings (counts) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(number of awakenings)_T3
时间窗: 3 month follow-up
Change in objective sleep parameters measured by actigraphy. Number of awakenings (counts) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep efficiency)_T0
时间窗: Baseline
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep efficiency)_T1
时间窗: 4 weeks
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep efficiency)_T2
时间窗: 1 month follow-up
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Change in objective sleep parameter(sleep efficiency)_T3
时间窗: 3 month follow-up
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
CPAP Adherence_T0
时间窗: Baseline
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
CPAP Adherence_T1
时间窗: 4 weeks
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
CPAP Adherence_T2
时间窗: 1 month follow-up
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
CPAP Adherence_T3
时间窗: 3 month follow-up
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
次要结局
未报告次要终点
研究者
Yen-Chin Chen
Associate Professor
National Sun Yat-sen University