MedTrace Logo

Digital Management of Sleep Health

NCT06481423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2025-06-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

dCBT-I

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.

BEHAVIORAL

Relaxing music

Participants can freely listen relaxing music

Sponsors & Collaborators

  • Jia Xiu

    lead OTHER

Principal Investigators

  • Shouyan Wang, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481423 on ClinicalTrials.gov