For more information, please use the contact form at the bottom of this page.
For more information, please use the contact form at the bottom of this page.
You may be eligible to participate in this trial if you meet the following criteria:
Mild or moderate traumatic brain injury or concussion exposure at least 1-year prior
U.S. Service Member Veterans and Active Duty Military
Age 18-75 years
Approximately 4 months
This randomized clinical trial tests whether HBOT can help reduce symptoms after traumatic brain injury compared to inactive (or placebo) HBOT. We are recruiting U.S. Service Members and Veterans. The total length of time for the study is approximately 4 months. Participants will complete 40 daily HBOT dives and three sets of questionnaires, blood draws, and brain games.
Actively Enrolling.
Active or inactive HBOT.
Approximately 12 weeks of daily sessions.
University of South Florida, Health Campus 13220 Laurel Drive Tampa, FL 33612
How It works 
The Study Process This is a double-blind, sequential adaptive randomized controlled trial evaluating the impacts of 100% hyperbaric oxygen therapy administered at 2.0 atmosphere absolute (ATA) for 40 daily sessions. Inactive HBOT/Placebo group participants will receive 21% oxygen therapy in a non-pressurized hyperbaric oxygen chamber. Participants will be unblinded at two weeks after the last dive. Participants in the placebo group will be offered the chance to receive the active HBOT after their completion of 40 placebo/inactive sessions.
Participants will undergo baseline testing for neurobehavioral function, self-reported symptoms, and blood work for inflammation biomarkers. They will have the option of giving a stool sampling, completing an EEG, and wearing a sleep monitoring device. Participants will complete a 2-week post-treatment assessment.
Treatment schedules may be adjusted as necessary so long as the 40 treatments are completed within a 12-week period.
Participants may not be enrolled in another clinical trial at the time of enrollment.
Answer: Clinical trials provide opportunities for doctors and scientists to learn more about how to treat people with traumatic brain injury (TBI). Without willing participants, new treatments would never be discovered. Participating in this study is a unique opportunity to contribute to groundbreaking research that could change the lives of fellow veterans suffering from traumatic brain injuries. In addition to helping physician-scientists develop new, effective treatments, patients are also taking an active role in their own recovery journey. Participants will receive comprehensive health tests and monitoring at no cost, ensuring you get the best possible care while helping pave the way for future advancements in TBI treatment. Participation could be the key to unlocking a better quality of life for yourself and others.
Answer: Clinical trials provide opportunities for doctors and scientists to learn more about how to potentially treat people with traumatic brain injury. Without willing participants, new treatments would never be discovered. It is also an opportunity to receive additional health tests and monitoring at no cost to you. Participating in this clinical trial is a unique opportunity to contribute to groundbreaking research that could change the lives of fellow veterans suffering from traumatic brain injuries. By joining, you’re not just helping doctors and scientists develop new, effective treatments, you are also taking an active role in your own recovery journey. You will receive comprehensive health tests and monitoring at no cost, ensuring you get the best possible care while helping pave the way for future advancements in TBI treatment. Your participation could be the key to unlocking a better quality of life for yourself and others.
Answer: Participation in this clinical trial is entirely voluntary. You are under no obligation to enroll, and if you decide to join, you can withdraw at any time without any consequences. Your choice and comfort are our priorities.
Answer: Side effects of hyperbaric oxygen therapy are uncommon, but it is possible to experience some ear or sinus pain. There are some more serious risks, which may include changes to your vision, lung or heart problems, or onset of seizures. It is important to alert your study team if you are experiencing any symptoms during your participation in the study so they can take proper measures to protect your health.
Answer: Yes, compensation for your time and effort to participate in this study will be provided. Your contribution is highly valued, and we want to ensure that you are recognized for your commitment. You will be compensated $2900 if all activities are completed.
Answer: We understand your concerns. In this double-blind study, neither you nor the researchers will know if you were in the treatment or inactive/placebo HBOT group until after the sessions are completed. If you were placed in the placebo group, you will have the opportunity to receive the full 40 sessions of pressurized oxygen therapy after the study. Your participation is vital for advancing TBI treatment and ensures you still benefit from the therapy. Your involvement will make a significant difference for fellow veterans.
If you are interested in learning more about this clinical trial or interested in participating, please complete the form below and we will contact you with more information. Fields marked with an * are required. Your answers will not be stored or shared with anyone outside of our organization.