Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of South Florida

About this trial

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

Eligibility criteria

Qualifiers

U.S. Service Members and Veterans, between 18 and 75 years of age

Ability to read, write, and speak English.

Ability to provide informed consent.

History of TBI. Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate as determined by with the Ohio State University TBI Identification Method (Bogner, 2009).

Disqualifiers

Received HBOT within the last 3 months.

Concurrently enrolled in another clinical trial.

Pregnancy or plans to become pregnant during the study period.

Lactating

Trial design

Treatments tested in this trial

  • Oxygen 99.7 %
  • Oxygen 21 %

Treatment groups

420 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of South Florida

Lead sponsor

James A. Haley Veterans' Hospital (JAHVH)

Collaborator