NCT06581003 · University of South Florida
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
What this study is about
The goal of this blinded, adaptive, randomly assigned, compared against an inactive treatment 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.
View original scientific 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.
Interventions
DRUG
Oxygen 99.7 %
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.
DRUG
Oxygen 21 %
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.
Primary outcome measures
Change from Baseline in the Neurobehavioral Symptoms at 2 weeks Post Intervention
Time frame: at 2 weeks post treatment
Measured by the Neurobehavioral Symptom Inventory (NSI). The severity of each symptom on the NSI is measured using a 5-item scale (0-none to 4-very severe) that asks patients to indicate the extent to which each symptom has disturbed them in the previous 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms. Cluster scores (domains: physical, cognitive, affective, and sensory) were derived.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- 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.
- Able to tolerate the HBOT environment lying down for one hour.
Exclusion criteria
- Received HBOT within the last 3 months.
- Concurrently enrolled in another clinical trial.
- Pregnancy or plans to become pregnant during the study period.
- History of retinal repair
- Malignancy:
- Tumor-related chemotherapy within the prior 6 months
- Therapeutic radiation to the central nervous system within the prior year
- 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?
- Chronic use of supplemental oxygen or hypoxemia while breathing room air.
- Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax
- Congestive heart failure with ejection fraction \< 40%
- Any implanted devices not cleared for hyperbaric pressurization\*.
- Epilepsy and/ or seizures
- Scuba diving within the previous month
- Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener
- Trapped gas observed indicating Bronchospasm present Tension Pneumothorax
- Evidence of Noncompliant TM (Until corrected)
- Evidence of Pneumothorax
- Evidence of Upper Respiratory Tract Infections
- Signs and symptoms of viral infections, such as high fevers
- Emphysema with CO2 retention
- Optic Neuritis
- Congenital spherocytosis
- History of middle ear surgery / disorders
- Pneumocephalus
- Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days.
- Antabuse because it predisposes to oxygen toxicity.
- 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.
- Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\
Where
- Tampa, Florida
Collaborators
James A. Haley Veterans' Hospital (JAHVH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations