Digital management of sleep health for chronic insomnia
Digital Management of Sleep Health
This study tests whether a smartphone app that offers digital therapy for insomnia can help people with chronic sleep problems sleep better compared to a relaxation training program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06481423 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) delivered through a smartphone app called 'ForSleep'. Participants will be randomly assigned to either the dCBT-I group or a control group receiving relaxation training. The study will track improvements in sleep quality using various scales and daily sleep diaries over a period of five weeks, including three weeks of intervention and two weeks of follow-up. All assessments and interventions are conducted online, ensuring accessibility for participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with moderate insomnia severity who are proficient in smartphone use and are native Chinese speakers.
Not a fit: Patients with other sleep disorders, severe neurological or mental health conditions, or those engaged in high-risk jobs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality for patients suffering from chronic insomnia.
How similar studies have performed: Other studies have shown promising results with digital cognitive behavioral therapy for insomnia, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 years old * Insomnia Severity Index Scale (ISI) score of 8\~21 * Proficient in the use of smartphones * Chinese native speaker Exclusion Criteria: * 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.)
Where this trial is running
Shanghai, Shanghai
- Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jia Xiu, B.S.
- Email: 22110850035@m.fudan.edu.cn
- Phone: +86 15552382909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.