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

NCT07521319 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-07-31
Completion
2030-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521319 on ClinicalTrials.gov