Chronic InsomniaNCT06658184
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients
A study testing sleep hygiene education in people with Chronic Insomnia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
About this study
Official title: Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\' sleep habits and maladaptive sleep behaviors.
Read the 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
- Being tested
- sleep restriction and stimulus control, sleep hygiene education
- Keywords
- chronic insomnia, sleep restriction, stimulus control, sleep hygiene education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep restriction and stimulus controlBehavioural
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 educationBehavioural
Sleep hygiene education:
- Sleep until feeling refreshed the next day.
- Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach.
- Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances.
- Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake.
- Avoid bringing problems to bed and refrain from attempting to sleep.
- Place the alarm clock under the bed or move it away from sight.
| Study group | Role | What they receive |
|---|---|---|
| sleep restriction and stimulus control | Experimental | Not described Receives: Behavioral: sleep restriction and stimulus control |
| Sleep hygiene education | Active comparator | Not described Receives: Behavioral: sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks
Secondary outcomes (12)
The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months
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.
Measured: 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
The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
Measured: 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
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency)
Measured: 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
The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.
Measured: 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
The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months
The SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months
The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Dec 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658184
- Sponsor's protocol ID
- SR-SC-insomnia
- Status last verified
- May 2025
- First submitted
- 23 Oct 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
- ClinicalTrials.gov ID
- NCT06658184
- Acronym / sponsor ID
- SR-SC-insomnia
- Conditions
- Chronic Insomnia
- Keywords
- chronic insomnia, sleep restriction, stimulus control, sleep hygiene education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep restriction and stimulus control | Experimental | Behavioral: sleep restriction and stimulus control |
| Sleep hygiene education | Active comparator | Behavioral: sleep hygiene education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep restriction and stimulus controlSleep 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. | Behavioural | sleep restriction and stimulus control |
| sleep hygiene educationSleep 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. | Behavioural | Sleep hygiene education |
Primary outcome
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
Time frame: Baseline, 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.
12 secondary outcomes
The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep hygiene education in people with Chronic Insomnia, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxing Wang, MD & PhD (+86 13911127385, wanghongxing@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.