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Clinical Trials in China / NCT06658184
Recruiting Not applicable

Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

NCT06658184 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-12-01
Last updated
2025-05-09

Condition(s) studied

Chronic Insomnia

Investigational drug(s) / intervention(s)

sleep restriction and stimulus controlsleep hygiene education

sleep restriction and stimulus control: Sleep restriction: a) Reduce bedtime to match actual sleep time, but ≥4.5 hours, and adjust bedtime according to sleep efficiency; b) Avoid daytime naps and maintain a regular wake-up time. Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being in bed, leave the bedroom and engage in relaxation activities until feeling sleepy, then return to bed for sleep; if still unable to fall asleep within about 20 minutes, repeat the process; e) Wake up at the same time every morning, including weekends.

sleep hygiene education: Sleep hygiene education: 1. Sleep until feeling refreshed the next day. 2. Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach. 3. Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances. 4. Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake. 5. Avoid bringing problems to bed and refrain from attempting to sleep. 6. Place the alarm clock under the bed or move it away from sight.

Study summary

The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\' sleep habits and maladaptive sleep behaviors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China Recruiting

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06658184 on ClinicalTrials.gov ↗ ← All trials in China