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

Sponsor
National Sun Yat-sen University
Study ID
NCT07521319
Status
Not Yet Recruiting

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Conditions

  • Comorbid Insomnia and Sleep Apnea
  • Insomnia
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
361 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • Active Comparator: Smart Eye-Mask Alone
    Participants use smart eye-mask with voice-guided modules nightly for 4 weeks without structured BBTi intervention.
  • No Intervention: Standard Sleep Hygiene Education
    Participants receive standard sleep hygiene education materials only.

Primary Outcome Measure

Change in Insomnia Severity Index (ISI)_T0 [ Time Frame: Baseline ]

Central Contacts

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