NCT07214415 Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
| NCT ID | NCT07214415 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Summit Hyperbarics and Wellness |
| Condition | TBI Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 54 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. 1. Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores? 2. To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Veteran status 3. Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional. 4. The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently. 5. Exposed to at least one trauma-focused therapy or evidence-based psychotherapeutic treatment, such as prolonged exposure therapy, EMDR, or CBT, to name a few. 6. Completed cognitive and psychological measurements. 7. Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity. 8. Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session. 9. Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers). Exclusion Criteria: 1. Untreated pneumothorax 2. History of spontaneous pneumothorax 3. Severe sinus infection 4. Upper respiratory infection 5. Asymptomatic pulmonary lesions on chest x-ray 6. Uncontrollable high fever (greater than 39C) 7. History of chest or ear surgery 8. Congenital spherocytosis 9. Any anemia or blood disorder 10. Any convulsive disorder 11. History of optic neuritis or sudden blindness 12. Middle ear infection 13. Diabetes mellitus (insulin therapy) 14. The subject is pregnant or lactating 15. Nicotine use/substance use/addiction 16. Acute Hypoglycemia 17. Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema 18. Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds. 19. Active malignancy 20. Current manic, delusional, or psychotic episodes 21. Serious/current suicidal ideations 22. Severe or unstable physical disorders or major cognitive deficits 23. Inability to attend scheduled clinic visits or comply with study protocols. 24. Treated with HBOT for any reason prior to study enrollment. 25. Non-English speakers 26. History of retinal repair, including laser photocoagulation or retinal detachment surgery. 27. History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement. 28. Age greater than 75 years. 29. Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapuetic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.
Contact & Investigator
Steven Wyman, MD
PRINCIPAL INVESTIGATOR
Summit Hyperbarics and Wellness
Frequently Asked Questions
Who can join the NCT07214415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying TBI Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07214415 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07214415 currently recruiting?
Yes, NCT07214415 is actively recruiting participants. Contact the research team at tnickel@shwidaho.org for enrollment information.
Where is the NCT07214415 trial being conducted?
This trial is being conducted at Boise, United States.
Who is sponsoring the NCT07214415 clinical trial?
NCT07214415 is sponsored by Summit Hyperbarics and Wellness. The principal investigator is Steven Wyman, MD at Summit Hyperbarics and Wellness. The trial plans to enroll 54 participants.