Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID06581003

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Led by University of South Florida · Updated on 2025-11-19

420

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of South Florida

Lead Sponsor

J

James A. Haley Veterans' Hospital (JAHVH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating hyperbaric oxygen therapy (HBOT) as a potential treatment for mild to moderate traumatic brain injury (TBI) in Veterans and active military personnel. This randomized, placebo-controlled, quadruple-blinded Phase 3 trial aims to determine if HBOT reduces neurobehavioral symptoms, the number of sessions needed for symptom improvement, and whether it lessens posttraumatic stress disorder (PTSD) symptoms. Additional exploratory goals include assessing changes in cognitive function, inflammation markers, microbiome, EEG, sleep, and brain imaging. Participants will receive 40 sessions of either HBOT or a placebo treatment within 12 weeks. The HBOT group will undergo treatment in a chamber pressurized to 2 ATA with 100% oxygen for 60 minutes per session. The placebo group will be in a chamber at normal atmospheric pressure with 21% oxygen. Blood pressure, breathing rate, pulse, and glucose levels (if diabetic) will be monitored during each session. Assessments will be conducted every 5 and 10 sessions, including self-reports and physical exams. After completing the treatment sessions, participants can learn which group they were in and those in the placebo group may have the option to receive the actual HBOT. Participants will complete baseline assessments, including questionnaires, interviews, cognitive tests, blood draws, and physical exams, to confirm eligibility. Mid-treatment and post-treatment visits will reassess symptoms and collect blood samples. Outcome measures focus on changes in neurobehavioral symptoms and PTSD at two weeks post intervention. The study includes monitoring for safety and symptom changes throughout, with regular evaluations of participant well-being and treatment effects over the trial duration.

CONDITIONS

Brief Title

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 mild to moderate traumatic brain injury at least 1 year prior, confirmed by Ohio State University TBI Identification Method
  • Experiencing chronic symptoms of TBI with a Neurobehavioral Symptom Inventory (NSI) score of 22 or higher
  • Able to tolerate lying down in the hyperbaric oxygen treatment environment for one hour
Not Eligible

You will not qualify if you...

  • Received hyperbaric oxygen therapy within the last 3 months
  • Currently enrolled in another clinical trial
  • Pregnant or planning to become pregnant during the study period
  • Lactating
  • History of retinal repair
  • Active malignancy or recent tumor-related chemotherapy or radiation
  • Diagnosis of bipolar disorder type I or schizophrenia
  • Chronic use of supplemental oxygen or hypoxemia on room air
  • Untreated asthma, bronchial obstruction, pulmonary blebs, or recent pneumothorax
  • Congestive heart failure with ejection fraction less than 40%
  • Implanted devices not cleared for hyperbaric pressurization
  • Epilepsy or seizures
  • Scuba diving within the previous month
  • Current suicidal intent as measured by Columbia-Suicide Severity Rating Scale
  • Signs of trapped gas, bronchospasm, tension pneumothorax, or pneumothorax
  • Noncompliant tympanic membrane until corrected
  • Upper respiratory tract infections or viral infections with high fever
  • Emphysema with CO2 retention
  • Optic neuritis
  • Congenital spherocytosis
  • History of middle ear surgery or disorders
  • Pneumocephalus
  • Recent diarrhea, vomiting, or antibiotic use affecting stool samples
  • Use of medications predisposing to oxygen toxicity such as Antabuse, Disulfuram, Acetazolamide, Sulfamylon, bleomycin, cisplatin, or doxyrubicin
  • Inability to complete MRIs due to claustrophobia, pacemaker, or ferromagnetic implants (for optional fMRI sub-study)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

2 visits (Baseline A and Baseline B in-person sessions)

Treatment

Duration - 12 weeks

Participants are randomized to receive either hyperbaric oxygen treatment (HBOT) or a placebo treatment. They will complete 40 treatment sessions called "dives" over 12 weeks in a specialized chamber. Each dive lasts about 76 minutes including 60 minutes of oxygen exposure. Participants will have their vital signs monitored during each dive and complete self-report and physical assessments at scheduled intervals.

40 dives with monitoring; assessments every 5 and 10 dives; 1 mid-treatment assessment visit

Follow-up

Duration - Approximately 2 weeks

Participants will complete a post-treatment assessment approximately 2 weeks after the last treatment session. This visit includes self-report measures, interviews, blood draw, and questions about treatment beliefs and impressions of change. After this visit, participants will be informed of their treatment group and placebo participants may opt for actual treatment.

1 post-treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

E

Erik Velasquez

R

Rachel A Karlnoski, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A comparison of two hyperbaric oxygen regimens: 2.0 ATA for 120 minutes to 2.4 ATA for 90 minutes in treating radiation-induced cystitis Are these regimens equivalent?

Olayinka D Ajayi, Zachary Gaskill, Matthew Kelly...

https://pubmed.ncbi.nlm.nih.gov/33227834

A Systematic Review and Meta-analysis on PTSD Following TBI Among Military/Veteran and Civilian Populations.

Alexandra Loignon, Marie-Christine Ouellet, Geneviève Belleville

https://pubmed.ncbi.nlm.nih.gov/31479073

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.

Dawn Neumann, Ambuj Kumar, Harry Van Loveren...

https://pubmed.ncbi.nlm.nih.gov/41882764

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.

Katherine F Walters, John M Templeton, Harry van Loveren...

https://pubmed.ncbi.nlm.nih.gov/41692764