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Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site contact updatedv5
  2. Site contact updatedv4
  3. Eligibility criteria expanded, about 26 words
    • Study description expanded, about 66 words
    v3
  4. Phase: Phase 4 to Phase 3
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2024 to Sep 18, 2024
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit
Trial Details
NCT Number NCT06581003
Lead Sponsor University of South Florida
Collaborators: James A. Haley Veterans' Hospital (JAHVH)
Conditions
(from sponsor)		 Traumatic Brain Injury, Military Operations
Related terms Brain Injuries, Traumatic
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov