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NCT Number: NCT07521319

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

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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Key information

Conditions

Comorbid Insomnia and Sleep Apnea Apnea Dyssomnias Insomnia Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Behavioral Therapy for Insomnia (BBTI)

Behavioral

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

Device

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 outcomes

  1. Change in Insomnia Severity Index (ISI)_T0

    Time frame: 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.

  2. Change in Insomnia Severity Index (ISI)_T1

    Time frame: 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.

  3. Change in Insomnia Severity Index (ISI)_T2

    Time frame: 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.

  4. Change in Insomnia Severity Index (ISI)_T3

    Time frame: 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.

  5. Change in Arousal Predisposition Scale (APS)_T0

    Time frame: Baseline

    Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.

  6. Change in Arousal Predisposition Scale (APS)_T1

    Time frame: 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.

  7. Change in Arousal Predisposition Scale (APS)_T2

    Time frame: 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.

  8. Change in Arousal Predisposition Scale (APS)_T3

    Time frame: 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.

  9. Change in Pre-Sleep Arousal Scale (PSAS)_T0

    Time frame: 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.

  10. Change in Pre-Sleep Arousal Scale (PSAS)_T1

    Time frame: 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.

  11. Change in Pre-Sleep Arousal Scale (PSAS)_T2

    Time frame: 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.

  12. Change in Pre-Sleep Arousal Scale (PSAS)_T3

    Time frame: 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.

  13. Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0

    Time frame: 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.

  14. Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1

    Time frame: 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.

  15. Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2

    Time frame: 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.

  16. Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3

    Time frame: 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.

  17. Change in subjective sleep diary_T0

    Time frame: 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).

  18. Change in subjective sleep diary_T1

    Time frame: 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).

  19. Change in subjective sleep diary_T2

    Time frame: 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).

  20. Change in subjective sleep parameter_T3

    Time frame: 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).

  21. Change in Epworth Sleepiness Scale (ESS)_T0

    Time frame: 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.

  22. Change in Epworth Sleepiness Scale (ESS)_T1

    Time frame: 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.

  23. Change in Epworth Sleepiness Scale (ESS)_T2

    Time frame: 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.

  24. Change in Epworth Sleepiness Scale (ESS)_T3

    Time frame: 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.

  25. Change in objective sleep parameter(total sleep time)_T0

    Time frame: 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.

  26. Change in objective sleep parameter(total sleep time)_T1

    Time frame: 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.

  27. Change in objective sleep parameter(total sleep time)_T2

    Time frame: 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.

  28. Change in objective sleep parameter(total sleep time)_T3

    Time frame: 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.

  29. Change in objective sleep parameter(sleep latency)_T0

    Time frame: 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.

  30. Change in objective sleep parameter(sleep latency)_T1

    Time frame: 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.

  31. Change in objective sleep parameter(sleep latency)_T2

    Time frame: 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.

  32. Change in objective sleep parameter(sleep latency)_T3

    Time frame: 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.

  33. Change in objective sleep parameter(number of awakenings)_T0

    Time frame: 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.

  34. Change in objective sleep parameter(number of awakenings)_T1

    Time frame: 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.

  35. Change in objective sleep parameter(number of awakenings)_T2

    Time frame: 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.

  36. Change in objective sleep parameter(number of awakenings)_T3

    Time frame: 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.

  37. Change in objective sleep parameter(sleep efficiency)_T0

    Time frame: 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.

  38. Change in objective sleep parameter(sleep efficiency)_T1

    Time frame: 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.

  39. Change in objective sleep parameter(sleep efficiency)_T2

    Time frame: 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.

  40. Change in objective sleep parameter(sleep efficiency)_T3

    Time frame: 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.

  41. CPAP Adherence_T0

    Time frame: 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%.

  42. CPAP Adherence_T1

    Time frame: 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%.

  43. CPAP Adherence_T2

    Time frame: 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%.

  44. CPAP Adherence_T3

    Time frame: 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Yen-Chin Chen

CONTACT

[email protected]

0963412677

Sponsors and collaborators

Lead sponsor

National Sun Yat-sen University

Other

Registry information

Official study 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

Acronym: BBTi-COMISA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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