Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481423
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
Digital Management of Sleep Health
Sponsor:
Jia Xiu
Organization:
Fudan University
Study Overview
Official Title:
Digital Management of Sleep Health
Status:
RECRUITING
Status Verified Date:
2024-06
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 goal of this clinical trial is to explore whether cognitive behavioral intervention for insomniaCBT-I realized through audio video and articles on smartphone appsForSleep developed by the investigators can improve the sleep quality of insomnia patients The main question it aims to answer is
Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia
Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality
Participants will be asked to
Use an appForSleep designed for CBT-I to follow a structured therapy program
Complete daily sleep diaries and periodic scales to track their sleep quality
Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia
Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality
Participants will be asked to
Use an appForSleep designed for CBT-I to follow a structured therapy program
Complete daily sleep diaries and periodic scales to track their sleep quality
Detailed Description:
All participants sign the informed consent form online The study is an online single-blind parallel-group superiority randomized experiment of digital CBT-IdCBT-I The randomization is performed using stratified random sampling to ensure non-significant differences in age gender and basic sleep quality between the two groups The screening informed consent assessments allocation to conditions delivery of the interventions scale evaluations and follow-ups are all carried out online WeChat chatting groups for daily notification and communication are set up respectively The experiment lasts 5 and more weeks included 3 weeks of intervention and 2 weeks of follow-up
All participants are required to keep sleep diaries They self-evaluate via Insomnia Severity Index ISI Dysfunctional Beliefs and Attitudes about Sleep DBAS Sleep Hygiene Index SHI and Epworth Sleepiness Scale ESS to assess insomnia severity sleep-related cognition and behaviors at 5 time points The first 3 times are at the first day after 7 days and 14 days before starting each new session After 3-week program the above scales are retaken during days 2225 and days 3639 as follow-ups The evaluating time is different on account of individual rate of progress to accomplish the 3-week program
Digital cognitive behavioral therapy is delivered using an app developed by Fudan University Digital intervention is structured into 3 sessions with a 7-days course in each session The intervention group undertook 3 weeks of tasks which consisted of cognitive behavioral and relaxation parts of CBT-I and typically lasted 15 minutes per day Two pieces of relaxing music are recommended daily to the control group instead of the standard relaxation practice All participants have access to 30 relaxing music and articles on sleep hygiene that are made available in the app
All participants are required to keep sleep diaries They self-evaluate via Insomnia Severity Index ISI Dysfunctional Beliefs and Attitudes about Sleep DBAS Sleep Hygiene Index SHI and Epworth Sleepiness Scale ESS to assess insomnia severity sleep-related cognition and behaviors at 5 time points The first 3 times are at the first day after 7 days and 14 days before starting each new session After 3-week program the above scales are retaken during days 2225 and days 3639 as follow-ups The evaluating time is different on account of individual rate of progress to accomplish the 3-week program
Digital cognitive behavioral therapy is delivered using an app developed by Fudan University Digital intervention is structured into 3 sessions with a 7-days course in each session The intervention group undertook 3 weeks of tasks which consisted of cognitive behavioral and relaxation parts of CBT-I and typically lasted 15 minutes per day Two pieces of relaxing music are recommended daily to the control group instead of the standard relaxation practice All participants have access to 30 relaxing music and articles on sleep hygiene that are made available in the app
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