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Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Insomnia Clinical Trial

Official title:
A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia

Clinical Trial Summary

The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients

Clinical Trial Description

The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline. During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc. For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2). ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT06339853
Study type Interventional
Source Yonsei University
Contact
Status Completed
Phase N/A
Start date September 7, 2023
Completion date February 29, 2024
View Details
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