Hyperbaric oxygen for thinking, mental health, and quality of life in veterans

Evaluating the Effects of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans

This trial will try hyperbaric oxygen therapy to see if it improves thinking, PTSD symptoms, mood, anxiety, and overall quality of life in veterans with mild TBI or related conditions.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Summit Hyperbarics and Wellness (Academic / other)
• Drugs / interventions: methotrexate, cyclophosphamide
• Locations: 1 site (Boise, Idaho)
• Trial ID: NCT07214415 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives enrolled veterans a course of hyperbaric oxygen therapy and measures cognitive function, PTSD, depression, anxiety, and quality of life before and after treatment. Participants must be adults with a clinical diagnosis of mild TBI, PTSD, anxiety, or depression, have completed baseline cognitive and psychological measurements, and have previously undergone trauma-focused therapy. Outcomes will be compared pre- and post-treatment and analyzed with statistical control for demographic characteristics. The protocol is conducted at a single commercial site (Summit Hyperbarics and Wellness) in Boise, Idaho.

Who should consider this trial

Good fit: Ideal candidates are veterans aged 18 or older with clinically diagnosed mild TBI, PTSD, anxiety, or depression who have completed baseline testing and prior trauma-focused therapy and can attend sessions in Boise, Idaho.

Not a fit: Patients without those diagnoses, those unable to travel to the single-site location, or those with medical contraindications to hyperbaric oxygen are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could improve cognitive functioning, reduce PTSD and mood symptoms, and raise overall quality of life for participating veterans.

How similar studies have performed: Previous studies of hyperbaric oxygen for TBI and PTSD have produced mixed results, with some small trials reporting gains in symptoms or cognition and others showing no clear benefit.

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.

Where this trial is running

Boise, Idaho

• Summit Hyperbarics and Wellness — Boise, Idaho, United States (Recruiting)

Study contacts

• Principal investigator: Steven Wyman, MD — Summit Hyperbarics and Wellness
• Study coordinator: Troy Nickel, PhD

Conditions TBI Traumatic Brain Injury; PTSD - Post Traumatic Stress Disorder; Post Concussive Syndrome