A Phase 2 interventional study of Hyperbaric Oxygen Therapy (HBOT) in Traumatic Brain Injury, Post-Concussive Symptoms and Post-Traumatic Stress Disorder, sponsored by Summit Hyperbarics and Wellness. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Summit Hyperbarics and Wellness · Phase 2, Interventional, and Treatment
This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.
This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended.
The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes.
The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status.
The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.
Exclusion Criteria:
Veterans who previously completed a standardized Hyperbaric Oxygen Therapy (HBOT) treatment protocol and undergo follow-up assessments approximately 12 weeks after their final treatment session to evaluate the long-term durability of cognitive, psychological, and quality-of-life outcomes.
Drug: Hyperbaric Oxygen Therapy (HBOT)
Hyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions.
Also known as: Hyperbaric Oxygen, Hyperbaric Oxygen Treatment
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: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Time frame: Baseline (post-HBOT completion) and 12 weeks after the 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, and environment facets
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Plan to share: No — Given that our study involves a relatively small cohort of veterans and includes sensitive cognitive and mental health data, we selected "no" to share IPD with other researchers.
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Summit Hyperbarics and Wellness