Comorbid Insomnia and Sleep ApneaBBTi-COMISANCT07521319
Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)
A study testing Brief Behavioral Therapy for Insomnia (BBTi) and Smart Eye-Mask with Voice-Guided Modules in people with Comorbid Insomnia and Sleep Apnea and Insomnia, run by National Sun Yat-sen University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Comorbid Insomnia and Sleep Apnea, Insomnia, Obstructive Sleep Apnea
- What is being tested?
- Brief Behavioral Therapy for Insomnia (BBTi) and Smart Eye-Mask with Voice-Guided Modules
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan
Yen-Chin Chen, PhD, 0963412677, yenchin2427@mail.nsysu.edu.tw
Cheng-Man NG, MS
About this study
Official 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
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.
Read the 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.
- Being tested
- Brief Behavioral Therapy for Insomnia (BBTi), Smart Eye-Mask with Voice-Guided Modules
- Keywords
- BBTi, COMISA, CPAP, Wearable Device, Sleep
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Therapy for Insomnia (BBTi)Behavioural
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 ModulesDevice
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 group | Role | What they receive |
|---|---|---|
| BBTi + Smart Eye-Mask | Experimental | 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. Receives: Behavioral: Brief Behavioral Therapy for Insomnia (BBTi); Device: Smart Eye-Mask with Voice-Guided Modules |
| BBTi Alone | Active comparator | Participants receive 4-week Brief Behavioral Therapy for Insomnia (BBTi) including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training. Receives: Behavioral: Brief Behavioral Therapy for Insomnia (BBTi) |
| Smart Eye-Mask Alone | Active comparator | Participants use smart eye-mask with voice-guided modules nightly for 4 weeks without structured BBTi intervention. Receives: Device: Smart Eye-Mask with Voice-Guided Modules |
| Standard Sleep Hygiene Education | No intervention | Participants receive standard sleep hygiene education materials only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)_T0
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Measured: Baseline
Change in Insomnia Severity Index (ISI)_T1
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Measured: 4 weeks
Change in Insomnia Severity Index (ISI)_T2
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Measured: 1 months follow-up
Change in Insomnia Severity Index (ISI)_T3
Change in insomnia severity measured by the ISI, a 7-item self-report questionnaire scored 0-28, with higher scores indicating more severe insomnia.
Measured: 3 months follow-up
Change in Arousal Predisposition Scale (APS)_T0
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Measured: Baseline
Change in Arousal Predisposition Scale (APS)_T1
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Measured: 4 weeks
Change in Arousal Predisposition Scale (APS)_T2
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Measured: 1 month follow-up
Change in Arousal Predisposition Scale (APS)_T3
Change in hyperarousal measured by the APS, an 12-item self-report questionnaire scored 12-60, with higher scores indicating greater daytime sleepiness.
Measured: 3 month follow-up
Change in Pre-Sleep Arousal Scale (PSAS)_T0
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.
Measured: Baseline
Change in Pre-Sleep Arousal Scale (PSAS)_T1
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.
Measured: 4 weeks
Change in Pre-Sleep Arousal Scale (PSAS)_T2
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.
Measured: 1 month follow-up
Change in Pre-Sleep Arousal Scale (PSAS)_T3
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.
Measured: 3 month follow-up
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0
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.
Measured: Baseline
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1
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.
Measured: 4 weeks
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2
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.
Measured: 1 month follow-up
Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3
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.
Measured: 3 month follow-up
Change in subjective sleep diary_T0
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).
Measured: Baseline
Change in subjective sleep diary_T1
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).
Measured: 4 weeks
Change in subjective sleep diary_T2
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).
Measured: 1 month follow-up
Change in subjective sleep parameter_T3
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).
Measured: 3 month follow-up
Change in Epworth Sleepiness Scale (ESS)_T0
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline
Change in Epworth Sleepiness Scale (ESS)_T1
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Measured: 4 weeks
Change in Epworth Sleepiness Scale (ESS)_T2
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Measured: 1 month follow-up
Change in Epworth Sleepiness Scale (ESS)_T3
Change in daytime sleepiness measured by the ESS, an 8-item self-report questionnaire scored 0-24, with higher scores indicating greater daytime sleepiness.
Measured: 3 months follow-up
Change in objective sleep parameter(total sleep time)_T0
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.
Measured: Baseline
Change in objective sleep parameter(total sleep time)_T1
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.
Measured: 4 weeks
Change in objective sleep parameter(total sleep time)_T2
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.
Measured: 1 months follow-up
Change in objective sleep parameter(total sleep time)_T3
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.
Measured: 3 months follow-up
Change in objective sleep parameter(sleep latency)_T0
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.
Measured: Baseline
Change in objective sleep parameter(sleep latency)_T1
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.
Measured: 4 weeks
Change in objective sleep parameter(sleep latency)_T2
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.
Measured: 1 month follow-up
Change in objective sleep parameter(sleep latency)_T3
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.
Measured: 3 month follow-up
Change in objective sleep parameter(number of awakenings)_T0
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.
Measured: Baseline
Change in objective sleep parameter(number of awakenings)_T1
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.
Measured: 4 weeks
Change in objective sleep parameter(number of awakenings)_T2
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.
Measured: 1 month follow-up
Change in objective sleep parameter(number of awakenings)_T3
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.
Measured: 3 month follow-up
Change in objective sleep parameter(sleep efficiency)_T0
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Measured: Baseline
Change in objective sleep parameter(sleep efficiency)_T1
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Measured: 4 weeks
Change in objective sleep parameter(sleep efficiency)_T2
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Measured: 1 month follow-up
Change in objective sleep parameter(sleep efficiency)_T3
Change in objective sleep parameters measured by actigraphy. Sleep efficiency (%) is automatically calculated and exported by the actigraphy device using its built-in algorithms.
Measured: 3 month follow-up
CPAP Adherence_T0
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
Measured: Baseline
CPAP Adherence_T1
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
Measured: 4 weeks
CPAP Adherence_T2
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
Measured: 1 month follow-up
CPAP Adherence_T3
CPAP usage compliance measured as the percentage of nights with CPAP use of 4 or more hours divided by total nights multiplied by 100%.
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbid Insomnia and Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 361 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Chin Chen, National Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521319
- Sponsor's protocol ID
- B-ER-115-008
- Acronym
- BBTi-COMISA
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No