Recruiting

Sleep Restriction and Stimulus Control for Chronic Insomnia

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What is being tested

sleep restriction and stimulus control

+ sleep hygiene education

Behavioral
Who is being recruted

Mental Disorders+3

+ Sleep Initiation and Maintenance Disorders

+ Nervous System Diseases

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorXuanwu Hospital, Beijing
Study ContactHongxing Wang, MD & PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on improving sleep quality for individuals with chronic insomnia who spend too much time in bed and have developed poor sleep habits. The research aims to test two strategies: sleep restriction and stimulus control. Sleep restriction involves reducing the amount of time spent in bed to better match the actual time spent sleeping, which can help enhance the efficiency and quality of sleep. Stimulus control is designed to create a stronger mental link between the bed and quickly falling asleep, reducing the negative feelings associated with being in bed but unable to sleep. Participants in the study will undergo a treatment that includes both sleep restriction and stimulus control techniques. These techniques are applied to see if they can help reduce insomnia symptoms and improve overall sleep quality. Sleep restriction involves adjusting the time participants are allowed to spend in bed, while stimulus control includes strategies to help them associate their bed with sleep rather than wakefulness. The study will monitor changes in sleep patterns and efficiency, although specific outcomes are not detailed. The goal is to find effective non-drug treatments for those struggling with chronic insomnia.

Official TitleEffects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
NCT06658184
Principal SponsorXuanwu Hospital, Beijing
Study ContactHongxing Wang, MD & PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

6 inclusion criteria required to participate
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.
Show More Criteria
4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Xuanwu Hospital, Capital Medical University

Beijing, ChinaOpen Xuanwu Hospital, Capital Medical University in Google Maps
Recruiting
One Study Center