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Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
NCT06581003Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2024
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- University of South Florida
- Modality
- Inhalation Devices
- Drugs
- oxygen
- Conditions
- traumatic brain injury (TBI)
01
Overview
Phase 3, randomised, double-blind trial of oxygen in traumatic brain injury (TBI) (2 arms), sponsored by University of South Florida. Primary endpoint: Change from Baseline in the Neurobehavioral Symptoms at 14 weeks. Started Sep 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
HBOT Group
HBOT chamber pressurized to 2.0 ATA with 100% oxygen for 60 minutes.
Placebo/Sham Group
Chamber remains unpressurized (1.0 ATA) and has 21% oxygen for 60 minutes.
03
Who it enrols
U.S. Service Members and Veterans with a history of mild to moderate TBI (minimum 1 year post-injury) experiencing chronic symptoms (NSI total score >= 22). Excludes patients with recent HBOT, pregnancy, active malignancy, bipolar I or schizophrenia, chronic supplemental oxygen use, untreated asthma, CHF with EF < 40%, epilepsy, and recent scuba diving.
04
Endpoints
Primary
Change from Baseline in the Neurobehavioral Symptoms
Secondary
Change from Baseline in post traumatic stress disorder symptoms
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