Improving sleep habits in chronic insomnia patients
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
This study is testing whether techniques to limit time in bed and improve bedtime habits can help people with chronic insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06658184 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effects of sleep restriction and stimulus control techniques on patients suffering from chronic insomnia. Sleep restriction involves reducing the time spent in bed to align more closely with actual sleep time, thereby enhancing sleep efficiency and quality. Stimulus control focuses on creating a positive association between the bed and falling asleep quickly, which helps to mitigate maladaptive sleep behaviors. Participants will also receive education on sleep hygiene to support their treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for insomnia disorder and have a Pittsburgh Sleep Quality Index score greater than 5.
Not a fit: Patients with severe physical or mental illnesses, sleep-breathing disorders, or those currently undergoing psychological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for patients with chronic insomnia.
How similar studies have performed: Previous studies have shown that behavioral interventions like sleep restriction and stimulus control can be effective in treating chronic insomnia, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the diagnostic criteria for insomnia disorder as per DSM-5. 2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5. 3. Age ≥ 18 years, at least a junior high school education level. 4. Assessment of sleep-wake behavior by sleep diary. 5. Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire. 6. Voluntary participation in the study and signing an informed consent form. Exclusion Criteria: 1. Presence of severe physical or severe mental illness, and suicide risk. 2. Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work. 3. Pregnant or lactating women. 4. Currently undergoing any form of psychological therapy.
Where this trial is running
Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Hongxing Wang, MD & PhD
- Email: wanghongxing@xwh.ccmu.edu.cn
- Phone: +86 13911127385
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.