Digital Management of Sleep Health

NCT06481423 | Completed

• 1 other identifier: FE22197I
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" 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 app("ForSleep") designed for CBT-I to follow a structured therapy program. Complete daily sleep diaries and periodic scales to track their sleep quality.

Conditions

Chronic Insomnia

Keywords

Digital cognitive behavior therapy for insomnia; Chronic Insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index Scale(PSQI)

  A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome

  baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

Secondary Outcomes (4)

• Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS)

  baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

• Sleep Hygiene Index Scale(SHI)

  baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

• The Insomnia Severity Index Scale(ISI)

  baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

• Epworth Sleepiness Scale(ESS)

  baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app

Behavioral: dCBT-I; Behavioral: Relaxing music

Control Group

OTHER

Participants can only freely access relaxing music in the app. They don't have access to dCBT-I

Behavioral: Relaxing music

Interventions

dCBT-I BEHAVIORAL

A digital cognitive behavioral intervention course that addresses multiple aspects such as basic sleep knowledge, sleep hygiene, sleep behaviors, improving negative cognition, and improving emotions. The intervention is delivered through video, audio, and text formats.

Intervention Group

Relaxing music BEHAVIORAL

Participants can freely listen relaxing music

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Insomnia Severity Index Scale (ISI) score of 8\~21
• Proficient in the use of smartphones
• Chinese native speaker

You may not qualify if:

• Those with other combined sleep problems, such as apnoea syndrome, restless leg syndrome, etc.
• Women during pregnancy
• risky jobs that require high concentration, such as working at heights, long-distance driving, etc.
• previous or current diagnosis of severe neurological disorders such as epilepsy
• previous or current diagnosis of mental illness such as depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, etc.
• history of drug or alcohol abuse
• a significant negative risk of suicide
• serious physical illness (e.g., cardiovascular, hepatic, renal, etc.)

Sponsors & Collaborators

• Jia Xiu: lead

Study Sites (1)

Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Shouyan Wang, PhD

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 1, 2024
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)