Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 1, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07852728). This is a study registration, not published results. Lead sponsor: Summit Hyperbarics and Wellness. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 54 participants (ESTIMATED). Conditions: Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Anxiety, Depression, Post Concussion Symptoms. Interventions: DRUG: Hyperbaric Oxygen Therapy (HBOT). Primary outcome measures: Change in NeuroTrax Global Cognitive Score , Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).; Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score , Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).. Brief summary: The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are: 1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions? 2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment? Approximately 54 participants will: * Complete medical and behavioral health screening. * Complete cognitive tests and questionnaires before and after treatment. * Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions. All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.