Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

NCT ID: NCT06658184

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

Brief 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.

Detailed Description

The purpose of sleep restriction is to reduce the patient's time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sleep restriction and stimulus control

Group Type: EXPERIMENTAL

sleep restriction and stimulus control

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

sleep hygiene education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Other Identifiers

SR-SC-insomnia

Identifier Type: -

Identifier Source: org_study_id