Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06581003
Phase
PHASE3
Status
Recruiting
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Conditions

  • Military Operations
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxygen 99.7 % — DRUG
    The experimental group will undergo HBOT in a specialized chamber at a pressure of 2.0 ATA. Oxygen will be delivered at 100% for 60 minutes.
  • Oxygen 21 % — DRUG
    The control group will be placed in the same specialized chamber, but pressure will be 1.0 ATA (normobaric), and oxygen will be delivered at 21% (normal oxygen concentration in room air) for 60 minutes.

Study Details

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

Key Dates

Start date
Sep 18, 2024
Status verified
Jan 2025
Primary completion
Aug 15, 2028
Completion
Aug 15, 2029

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HBOT Group
    HBOT chamber pressurized to 2.0 ATA with 100% oxygen
  • Sham Comparator: Placebo/Sham Group
    HBOT chamber that remains unpressurized and has 21% oxygen

Primary Outcome Measure

Change from Baseline in the Neurobehavioral Symptoms at 2 weeks Post Intervention [ Time Frame: at 2 weeks post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33612
Harry Van Loveren, MD (PRINCIPAL_INVESTIGATOR)
Dawn Neumann, PhD (PRINCIPAL_INVESTIGATOR)
Shannon Miles, PhD (SUB_INVESTIGATOR)

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By research site
University of South Florida· Tampa, FL

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