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 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT06358495
Eligibility Criteria:
Inclusion Criteria:
* Between the ages of 12 and 18.
* Having at least one parent with a history of depressive or anxiety disorders but having no clinically significant history (per the Diagnostic and Statistical Manual of Mental Disorders 5) of internalizing disorders themselves.
* Adolescents who score 10/25 or greater on the Insomnia Severity Index, indicating subthreshold insomnia or greater.
Exclusion Criteria:
* Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome \[RLS\], sleep-disordered breathing \[SDB\].
* Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia).
* Active suicidal ideation.
* Currently taking prescribed medications for sleep problems.
* Moderate to severe head injury.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT06358495
Study Brief:
Protocol Section:
NCT06358495