Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Relaxation training and stimulus control for chronic insomnia

Official title: Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns

Run by Xuanwu Hospital, Beijing · NCT06658171 · Data updated 2026-11-12

This study is testing whether relaxation techniques and better sleep habits can help people with chronic insomnia sleep better.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment88 (estimated)
SponsorXuanwu Hospital, Beijing
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedOctober 1, 2025
Study endsNovember 1, 2025
Registry record updatedMay 9, 2025
Trial IDNCT06658171 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for insomnia disorder and exhibit maladaptive sleep behaviors.

Probably not a fit

Patients with severe physical or mental disorders, sleep-related breathing disorders, or those currently undergoing psychological therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate the effects of relaxation training and stimulus control on patients suffering from chronic insomnia. The approach includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to reduce physical and psychological tension, thereby promoting better sleep. Additionally, stimulus control is employed to help patients break negative associations with their sleeping environment and foster positive sleep habits. The study will also incorporate sleep hygiene education to further support participants in improving their sleep quality.

Why it matters

Potential benefit: If successful, this study could significantly improve sleep quality and overall well-being for patients with chronic insomnia.

How similar studies have gone: Previous studies have shown positive outcomes with similar relaxation and stimulus control approaches in treating insomnia, indicating a promising avenue for this intervention.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Meet the diagnostic criteria for insomnia disorder according to DSM-5.
2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
3. Age ≥ 18 years, with at least a middle school education level.
4. Anxiety symptoms meeting HAMA ≥ 14.
5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
6. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
3. Pregnant or lactating women.
4. Currently undergoing any psychological therapy.

Where it's running

  • Xuanwu Hospital, Capital Medical University
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.