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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Obstructive Sleep Apnea; Comorbid Insomnia and Sleep Apnea
• Intervention / Treatment: Behavioral: Brief Behavioral Therapy for Insomnia (BBTi); Device: Smart Eye-Mask with Voice-Guided Modules

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.

• Study Type: Interventional
• Enrollment (Estimated): 361
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Chin Chen; Phone Number: 0963412677; Email: yenchin2427@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Device: 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.
Active Comparator: BBTi Alone; Participants receive 4-week Brief Behavioral Therapy for Insomnia (BBTi) including sleep hygiene education, sleep restriction, stimulus control, and relaxation/breathing training.	Behavioral: 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.
Active Comparator: Smart Eye-Mask Alone; Participants use smart eye-mask with voice-guided modules nightly for 4 weeks without structured BBTi intervention.	Device: 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.
No Intervention: Standard Sleep Hygiene Education; Participants receive standard sleep hygiene education materials only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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%.	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%.	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%.	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%.	3 month follow-up

Collaborators and Investigators

• Sponsor: National Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; CPAP; Wearable Device; BBTi; COMISA
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: B-ER-115-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No