This study investigates the how well it works 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 randomly assigned 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.
Official registry: https://clinicaltrials.gov/study/NCT07521319 · National Sun Yat-sen University · enrollment listed as 361
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Brief Behavioral Therapy for Insomnia (BBTi), or Smart Eye-Mask with Voice-Guided Modules. The registry lists allocation as randomized. This study investigates the how well it works 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).
They plan to enroll about 361 people at Tainan. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.
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
Interventions: Brief Behavioral Therapy for Insomnia (BBTi), Smart Eye-Mask with Voice-Guided Modules
Primary outcome (registry wording): Change in Insomnia Severity Index (ISI)_T0
Yen-Chin Chen
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
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NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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