Can pressurized oxygen heal Veterans' brain injuries? large trial launches
NCT ID NCT06581003
First seen Jun 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times
Summary
This study tests whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can reduce long-term symptoms like headaches, memory problems, and mood changes in veterans with mild to moderate traumatic brain injury. 420 veterans will receive either real HBOT or a placebo (normal air at room pressure) for 40 sessions over 12 weeks. Researchers will track symptom changes and also explore effects on thinking, sleep, and brain scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyperbaric oxygen therapy (99.7% oxygen at 2.0 ATA pressure)
- What this could lead to
- If it works, this could provide a new treatment option to ease long-term symptoms like headaches, memory problems, and mood changes after traumatic brain injury.
- What could go wrong
- This is a large Phase 3 trial, but the placebo group also receives mild pressure and normal air, which may still produce some benefit, making it hard to prove HBOT works. The 40-session commitment may also lead to dropouts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 420 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. U.S. Service Members and Veterans, between 18 and 75 years of age 2. Ability to read, write, and speak English. 3. Ability to provide informed consent. 4. 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). 5. Experiencing chronic symptoms of TBI as determined by at least a NSI total score of ≥22 (based on previous work using this score; Harch et al., 2020. 6. Able to tolerate the HBOT environment lying down for one hour. Exclusion Criteria: 1. Received HBOT within the last 3 months. 2. Concurrently enrolled in another clinical trial. 3. Pregnancy or plans to become pregnant during the study period. 4. Lactating 5. History of retinal repair 6. Malignancy: 1. Active 2. Tumor-related chemotherapy within the prior 6 months 3. Therapeutic radiation to the central nervous system within the prior year 7. Current diagnosis of bipolar disorder type I or schizophrenia as determined by responses to inquiry: Have you ever been diagnosed or prescribed medications for bipolar disorder or schizophrenia? 8. Chronic use of supplemental oxygen or hypoxemia while breathing room air. 9. Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax 10. Congestive heart failure with ejection fraction \< 40% 11. Any implanted devices not cleared for hyperbaric pressurization\*. 12. Epilepsy and/ or seizures 13. Scuba diving within the previous month 14. Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener 15. Trapped gas observed indicating Bronchospasm present Tension Pneumothorax 16. Evidence of Noncompliant TM (Until corrected) 17. Evidence of Pneumothorax 18. Evidence of Upper Respiratory Tract Infections 19. Signs and symptoms of viral infections, such as high fevers 20. Emphysema with CO2 retention 21. Optic Neuritis 22. Congenital spherocytosis 23. History of middle ear surgery / disorders 24. Pneumocephalus 25. Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days. 26. Antabuse because it predisposes to oxygen toxicity. 27. Other medications that would predispose to oxygen toxicity or known to increase drug toxicity will also be excluded. These are: Disulfuram, Acetazolamide, Sulfamylon; bleomycin, cisplatin, and doxyrubicin. 28. Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\* Exclusion criteria for fMRI optional sub-study only
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of South Florida
RECRUITINGTampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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