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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Insomnia Severity Index (ISI)_T0 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 subjective sleep diary_T1 — 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 — 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 — 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 — 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 — 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)_T2 — 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 Epworth Sleepiness Scale (ESS)_T3 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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%.

Trial sites (1)

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