Frequently Asked Questions

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.

Clinical trials are designed with safety as a top priority. However, as with anything unknown, there are some inherent risks that all participants should recognize, consider, and weigh for themselves. The study design goes through multiple screenings so that subject matter experts can ensure all reasonable precautions are considered and followed. For the HBOT trial, all technicians (those administering treatments) have undergone extensive training. Every protocol was approved by an independent research board. And we have highly qualified medical professionals available to assess any potential risks. In short, we feel that the study design and treatments have a very low risk of causing any type of personal harm.

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.

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.

Yes, compensation for your time and effort to participate in this study is provided. Your contribution is highly valued, and we want to ensure that you are recognized for your commitment. Successful completion of all study arms is valued at $2900 per person.

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.

90 min total, 76 in chamber

No, but medications that may interfere with HBOT treatment may be discussed further with our clinical care team to ensure safety and decide based on the specific medications.

USF Health north campus / Tampa.

No, the study is double blinded and the placebo treatment is designed to simulate active treatment.

Yes, we will ask you to cease scuba diving for a month prior to your first dive and throughout your participation for ~3-4 months.

We ask that you plan to come 3-5x per week for 12 weeks, but your specific dive schedule can be adjusted as needed.

Yes, as long as your concussion/TBI was >12 months ago.

Currently, potential participants for the main HBOT study is limited to military members only. We will have a qualitative sub-study involving family and spouses and we welcome your participation in these interviews if of interest. Please email mcom-talkhbot@usf.edu for additional information on the qualitative portion of the study involving family members and spouses, etc.

No, but we are happy to discuss the potential of qualifying for this study after your current clinical trial participation concludes.