Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339853
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2024-03-17
Brief Title:
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 selectionexclusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None