Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Sun Yat-sen University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Brief Behavioral Therapy for Insomnia (BBTi)
BehavioralA 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
DeviceA 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.
Treatment groups
361 Participants
are divided into 4 treatment groupsGroup A: BBTi + Smart Eye-MaskExperimental treatment 2 interventions
Group B: BBTi AloneActive comparator 1 intervention
Group C: Smart Eye-Mask AloneActive comparator 1 intervention
Group D: Standard Sleep Hygiene EducationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
4 weeks3
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.
Time frame
1 months follow-up4
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.
Time frame
3 months follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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