Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

Last updated: May 5, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Treatment

sleep hygiene education

sleep restriction and stimulus control

Clinical Study ID

NCT06658184
SR-SC-insomnia
  • Ages 18-65
  • All Genders

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 Criteria

Inclusion

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

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 shiftsor with shift work.

  3. Pregnant or lactating women.

  4. Currently undergoing any form of psychological therapy.

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: sleep hygiene education
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

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