NCT06581003

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Recruiting now Phase 3 Last updated 19 November 2025

What this trial tests

Phase 3 trial testing Oxygen 99.7 % in Traumatic Brain Injury in 420 participants. Currently enrolling.

Timeline

18 September 2024

Primary endpoint
15 August 2028

15 August 2029

Quick facts

Lead sponsor	University of South Florida
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	420
Start date	18 September 2024
Primary completion	15 August 2028
Estimated completion	15 August 2029
Sites	1 location across United States

Drugs / interventions tested

• Oxygen 99.7 % — full drug profile →
• Oxygen 21 % — full drug profile →

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Military Operations — all drugs for Military Operations →

Sponsor

University of South Florida

Who can join

Adults 18 to 75, any sex, with Traumatic Brain Injury or Military Operations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Hyperbaric Oxygen Treatment in Veterans and Service Members with Traumatic Brain Injury - A Study Protocol for a Blinded Group Sequential Randomized Controlled Trial
   Neumann D, Kumar A, Loveren Hv. · · 2025 · cited 1× · DOI 10.21203/rs.3.rs-6874662/v1
2. Efficacy of hyperbaric oxygen treatment in veterans and service members with traumatic brain injury-a study protocol for a blinded three-stage group sequential randomized controlled trial.
   Neumann D, Kumar A, Van Loveren H, USF HBOT for Veterans with TBI Collaborative Group. · · 2026 · PMID 41882764 · DOI 10.1186/s13063-026-09645-z
3. EEG as a diagnostic tool and therapeutic monitor in traumatic brain injury: a sub-study methodology from the hyperbaric oxygen treatment for veterans with traumatic brain injury randomized controlled trial.
   Walters KF, Templeton JM, van Loveren H, Yusuf FR, et al · · 2026 · PMID 41692764 · DOI 10.1186/s13063-026-09531-8