Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06658158
Eligibility Criteria:
Inclusion Criteria:
1. Meets the diagnostic criteria for insomnia disorder according to DSM-5;
2. PSQI total score \> 5;
3. Age ≥ 18 years, with at least a junior high school education;
4. Sleep cognitive distortions assessed using the DBAS-16;
5. "Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";
6. Willing to participate in the study and sign an informed consent form.
Exclusion Criteria:
1. Presence of severe physical illness or serious mental disorders, or at risk for suicide;
2. Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;
3. Pregnant or lactating women;
4. Currently undergoing any form of psychological therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06658158
Study Brief:
Protocol Section:
NCT06658158