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

NCT07521319 | Not Yet Recruiting

• 1 other identifier: B-ER-115-008
• Study Type: interventional
• Target: 361
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia; Obstructive Sleep Apnea; Comorbid Insomnia and Sleep Apnea

Keywords

BBTi; COMISA; CPAP; Wearable Device; Sleep

Outcome Measures

Primary Outcomes (44)

• 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

Study Arms (4)

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.

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.

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.

Device: Smart Eye-Mask with Voice-Guided Modules

Standard Sleep Hygiene Education

NO INTERVENTION

Participants receive standard sleep hygiene education materials only.

Interventions

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.

BBTi + Smart Eye-Mask; BBTi Alone

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.

BBTi + Smart Eye-Mask; Smart Eye-Mask Alone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Sun Yat-sen University: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yen-Chin Chen

CONTACT

0963412677; yenchin2427@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share