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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT04131868
Eligibility Criteria:
Inclusion Criteria:
* Insufficient sleep (total sleep time \< 8 hours per night, with sleepiness scores ≥ 6 on the Epworth Sleepiness Scale OR ≥ 16 on the PROMIS Sleep Related Impairment Scale)
* Symptoms of depression (≥ 15 on the Center for Epidemiological Studies for Depression Scale)
Exclusion Criteria:
* Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder
* History of head injury with loss of consciousness within the past two years
* History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome
* Neurological disorder
* Use of psychiatric medications
* Current psychotic symptoms
* Active suicidal ideation
* Conditions that are contraindicated for MRI (e.g., ferromagnetic material in the body)
* Meet criteria for current substance use disorder with greater than mild severity
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
22 Years
Study:
NCT04131868
Study Brief:
Protocol Section:
NCT04131868