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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT04885205
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 64 years old
* At least 4 weeks since concussion injury
* Self-report difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights per week since injury
* Score ≥10 on the Insomnia Severity Index to indicate clinical insomnia.
* Score ≥25 on the Mini-Mental State Examination (MMSE) questionnaire
Exclusion Criteria:
* Known untreated sleep disorder (such as sleep apnea, restless leg syndrome, circadian rhythm disorder, hypersomnia, parasomnias)
* Increased risk obstructive sleep apnea (STOP BANG Score ≥3)
* Increased risk of restless leg syndrome on RLS-Diagnosis Index
* Increased risk of circadian rhythm sleep-wake disorder (respond "Yes" to all circadian rhythm questions).
* Increased risk of parasomnia (Respond "Yes" to all questions for night mere disorder OR respond "Yes" to all REM sleep arousal disorder: Sleep walking questions, OR responds " Yes" to all REM sleep arousal disorder: Sleep Terrors questions, OR respond "Yes" to all REM sleep behavior disorder questions.)
* Active abuse or history (up to 2 years) of alcohol/ drug dependence as defined by the DSM-V criteria
* Severe mental illness such as schizophrenia or bipolar disorder
* Score of \> 29 on the Beck Depression Inventory or indication of suicidality (response of "2" or "3"to item 9)
* History of diagnosed nervous system disorder other than concussion (such as multiple sclerosis, Parkinson's Disease, Stroke)
* Currently works nightshift
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04885205
Study Brief:
Protocol Section:
NCT04885205