NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH) (NCT05375812) | Clinical Trial Compass
RecruitingNot Applicable
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
United States85 participantsStarted 2023-04-16
Plain-language summary
Background:
Gulf War illness (GWI) affects up to 210,000 U.S. veterans who served in the Middle East during the Gulf War in 1990-1991. Symptoms include fatigue, muscle and joint pain, forgetfulness, headaches, rashes, and sleep disturbances. Routine exams cannot determine the cause of GWI. Researchers need more information to understand this disease.
Objective:
This natural history study will look for differences in Gulf War veterans who experienced GWI and those who did not.
Eligibility:
Gulf War veterans with GWI. Healthy Gulf War veterans who do not have GWI are also needed.
Design:
Participants will stay in the NIH Clinical Center as an inpatient for 2 weeks. They will undergo many tests.
Blood will be drawn many times throughout the study. Participants will also give urine, saliva, and stool samples.
Scans to measure the brain, leg muscles, bone density and body mass will be done.
They will have an exercise stress test and muscle strength tests.
They will have a sleep study. They will have tests to look at how well the brain, heart and lungs are working.
Participants will sleep in a specialized room that measures the amount of oxygen they use and the carbon dioxide they produce on four consecutive nights.
A sample of fluid will be collected from inside the spine.
Participants will take many surveys. Some will ask about their activities. Some will be about emotional and mental health. Some will be about thinking, memory, and behavior.
Optional tests include other imaging scans and testing the autonomic nervous system. Samples of skin and muscle may be taken.
After discharge, participants will wear activity monitors for 14 days. They will keep a diary of their symptoms, including fatigue, pain, and sleep, while wearing the monitors....
Who can participate
Age range
48 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Inclusion criteria for all veterans:
* Ability to provide informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age 48-70 at time of enrollment into VA IN-DEPTH Study
* Veterans who were deployed to Gulf Region ODS/S between August 1990 - June 1991.
* Self-reported completion of at least the seventh grade of school.
* Fluency in speaking, reading, and understanding English.
* Underwent screening as part of the VA IN-DEPTH study and were unanimously determined to be eligible by the IN-DEPTH Adjudication Committee.
* Agree not to smoke in the 4 hours prior to CPET procedure
EXCLUSION CRITERIA:
Exclusion criteria for all veterans:
* Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia
* Current DSM-5-defined major depression disorder, generalized anxiety disorder, posttraumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
* Current or past substance use disorder within last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5). Prior or prescription marijuana use within the past five years will not be an exclusion.
* Current suicidal ideation
* History of head injury leading to moderate or severe traumatic brain injury, as detailed by loss of consciousness for greater than 30 minutes, a Glas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on 'deep phenotyping' — meaning detailed clinical and biological profiling — rather than testing a treatment, what would my family or I actually gain from participating, and would there be any direct health benefit for me?
2This trial is comparing Gulf War veterans who have Gulf War Illness to healthy veteran controls — does my specific symptom history and health profile fit the kind of participant they're looking for, and would you recommend I reach out to the research team?
3Because this is a baseline data-collection study at the NIH, can you help me understand what kinds of tests, samples, or evaluations I might be asked to go through, and whether any of those could be uncomfortable or carry risks?
4While this research might help scientists better understand Gulf War Illness over time, are there existing treatments or management strategies for my symptoms that we should be pursuing right now rather than waiting for research like this to translate into clinical care?
5If I participate in this observational study and my results reveal something unexpected about my health, would the NIH research team share those findings with me, and would you as my doctor be informed so we could follow up appropriately?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To explore and compare the clinical and biological phenotypes of veterans with GWI and healthy veteran controls (HVC) at baseline.
Timeframe: one time visit
Trial details
NCT IDNCT05375812
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)