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:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT06290492
Eligibility Criteria:
Inclusion Criteria:
1. age between 15 and 65 years,
2. diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017),
3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.
Exclusion Criteria:
1. diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome,
2. history of head trauma or presence of serious organic diseases,
3. presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale \[HAMA\] score of 17 or Hamilton Depression Scale \[HAMD\] score of 14.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
65 Years
Study:
NCT06290492
Study Brief:
Protocol Section:
NCT06290492