Comorbid Insomnia and Sleep Apnea, Insomnia, Obstructive Sleep Apnea
Conditions
Keywords
BBTi, COMISA, CPAP, Wearable Device, Sleep
Brief 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.
Detailed description
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.
Interventions
A 4-week structured behavioral sleep intervention including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training.
DEVICESmart 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.
Sponsors
National Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Contacts
CONTACTYen-Chin Chen
Outcome results
None listed