Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

NCT06658184 | Recruiting

• 1 other identifier: SR-SC-insomnia
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Keywords

chronic insomnia; sleep restriction; stimulus control; sleep hygiene education

Outcome Measures

Primary Outcomes (1)

• The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks

  The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.

  Baseline, 6 weeks

Secondary Outcomes (12)

• The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months

  baseline, 3 months, 6 months, and 12 months

• The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

• The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months

  Baseline, 6 weeks, 3 months, 6 months, and 12 months

Study Arms (2)

sleep restriction and stimulus control

EXPERIMENTAL

Behavioral: sleep restriction and stimulus control

Sleep hygiene education

ACTIVE COMPARATOR

Behavioral: sleep hygiene education

Interventions

sleep restriction and stimulus control 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 restriction and stimulus control

sleep hygiene education 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.

Sleep hygiene education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for insomnia disorder as per DSM-5.
• Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
• Age ≥ 18 years, at least a junior high school education level.
• Assessment of sleep-wake behavior by sleep diary.
• Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
• Voluntary participation in the study and signing an informed consent form.

You may not qualify if:

• Presence of severe physical or severe mental illness, and suicide risk.
• 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.
• Pregnant or lactating women.
• Currently undergoing any form of psychological therapy.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

CN (1)