A Phase 2 interventional study of Hyperbaric Oxygen Therapy in TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder and Post Concussive Syndrome, sponsored by Summit Hyperbarics and Wellness. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Summit Hyperbarics and Wellness · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
Exclusion Criteria:
Drug: Hyperbaric Oxygen Therapy
Each HBOT session is scheduled for approximately 95 minutes. The session will begin with a descent of up to 15 minutes (longer if needed for comfort/safety) to a pressure of 2.0 ATA, followed by 30 minutes of breathing 100% oxygen. At the midpoint, there will be a 5-minute air break from oxygen, after which subjects resume breathing 100% oxygen for another 30 minutes. Finally, the session will conclude with an ascent of up to 15 minutes (longer if needed for comfort/safety) back to 1.0 ATA. All sessions are delivered under direct medical supervision with standardized safety protocols. Once approved after medical and behavioral screening, participants complete a battery of cognitive, mental health, and quality of life assessments at baseline (pre-) and after completing the therapy (post-). This arm is distinct from any sham or control interventions because all participants receive the active HBOT treatment.
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
NeuroTrax
A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
World Health Organization Quality of Life (WHOQOL-BREF)
Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Plan to share: Undecided
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Summit Hyperbarics and Wellness