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 range48 Years – 70 Years

SexALL

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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…

What they're measuring

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)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Angelique A Gavin

(301) 402-0880 angelique.gavin@nih.gov