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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05248360
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
2. No use of sleep medications within the preceding 2 weeks, or a stable dose of only one sedative hypnotic medicine for at least 1 month before the enrollment and remain unchanged throughout the course of the study.
3. Signed informed consent form (ICF).
Exclusion Criteria:
1. Complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.);
2. Complicated with serious heart, lung, liver or renal diseases or malignant tumor;
3. History of mental illness;
4. Drugs or substances abuse;
5. Pregnant women, breast-feeding women or those with recent birth plans;
6. Participants in other clinical trials within 1 month before the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05248360
Study Brief:
Protocol Section:
NCT05248360