About the Trial
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-duty service military.
Who is Eligible?
U.S. Service Members and Veterans, between 18 and 75 years of age
History of Traumatic Brain Injury (TBI)
Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate
Experiencing chronic symptoms of TBI
Able to tolerate the HBOT environment lying down for one hour
How it works
Each participant will undergo a total of 40 HBOT dives over a span of 12 weeks. Each dive session takes approximately 90-minutes (~75 minutes in the HBOT chamber).
The Study Process
Throughout the study, participants will be asked to:
- Complete questionnaires.
- Complete brain games.
- Give blood samples to test for markers of inflammation.
Participants may also choose to participate in further testing, which will include:
- Giving a stool sample before and after the 40 dives.
- Receiving electroencephalogram (EEG) and more brain games.
- Accepting and agreeing to wear a device that will monitor sleep patterns.
Study Logistics
Category
Details
Timing
Actively Enrolling.
Main Intervention
Active or inactive HBOT.
Study Duration
Approximately 12 weeks of daily sessions.
Location
University of South Florida,
Health Campus
13220 Laurel Drive
Tampa, FL 33612
Exploratory Sub-Studies Available
- EEG readings at the USF Health site pre and post study intervention with main contact ___.
- Microbiome analysis through at home stool sample collections pre and post study intervention.
- fMRI reads pre and post HBOT treatments at the USF Health site.
- Qualitative interviews conducted virtually and at the USF Health site.
- Sleep wearable device: worn throughout the study duration to passively measure biometric data.
Logistics
Directions and parking information for the USF Health HBOT and fMRI Center (box link)