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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03998358
Eligibility Criteria:
* INCLUSION CRITERIA:
* Are 25 to 40 years of age
* Are active duty service members or veterans
* May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff
* Have sustained at least 1 TBI, \>= 6 months and \<= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call
* Are able to provide their own consent
* Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz
EXCLUSION CRITERIA:
* Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included.
* Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests.
* Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests.
* Have a major medical illness that is associated with fatigue (e.g., chronic fatigue \[diagnosed prior to their TBI or less than 6 months following TBI\], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report.
* Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report.
* Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report.
* Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam.
* Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test.
* Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report.
\*\*Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following:
* Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
* Claustrophobia
* Are not able to lie comfortably flat on their back for up to 60 minutes
\*\*Participant may be able to participate in the protocol but will not be able to have the hydrocortisone stimulation test if they have any of the following:
* History of endocrine disorder or dysfunction (including thyroid, adrenal, pancreatic and pituitary disorders)
* Abnormal lab values that may indicate endocrine disorder or dysfunction
* Mother who is currently nursing an infant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
40 Years
Study:
NCT03998358
Study Brief:
Protocol Section:
NCT03998358