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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT02374918
Eligibility Criteria:
Inclusion criteria:
* Age range between 18 and 50.
* The primary language of the subjects must be English.
* Subjects have experienced a "concussion" or mTBI within the preceding 18 months, but no sooner that 4 weeks prior to their screening. The occurrence of a concussion or mTBI must be documented by a medical report or other professional witness documentation.
* If documented, Glasgow Coma Scale in the range of 13-15 following the injury.
* Subjects must have complaints of sleep difficulties that emerged or worsened following the most recent head injury.
* At least half of subjects must have evidence of sleep onset insomnia or delayed sleep phase disorder.
Exclusion criteria:
* Any other history of neurological illness, current Diagnostic Statistical Manual (DSM-IV) Axis I disorder, lifetime history of psychotic disorder, or head injury with loss of consciousness \> 30 minutes
* Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV, brain tumor, etc.)
* Abnormal visual acuity that is not corrected by contact lenses
* Metal within the body, claustrophobia, or other contraindications for neuroimaging
* Less than 9th grade education
* Excess current alcohol use (more than 2 instances of intake of 5+ drinks (men) when or 4+ drinks (women) when drinking in the past two months, and/or on average drinking \> 2 drinks per day (men); \> 1 drinks per day (women) during the past two months
* History of alcoholism or substance use disorder
* Significant use of illicit drugs
* History of marijuana use within the past 6 weeks and/or use of marijuana before the age of 16.
Subjects who engage in shift-work, night work, or who have substantially desynchronized work-sleep schedules (i.e., sleeping later than 10:00 a.m. more than once a week) will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02374918
Study Brief:
Protocol Section:
NCT02374918