Status:
RECRUITING
Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
Lead Sponsor:
Summit Hyperbarics and Wellness
Conditions:
TBI Traumatic Brain Injury
PTSD - Post Traumatic Stress Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Veteran status
- 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.
- 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.
- 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.
- Completed cognitive and psychological measurements.
- Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
- 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.
- Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).
Exclusion
- Untreated pneumothorax
- History of spontaneous pneumothorax
- Severe sinus infection
- Upper respiratory infection
- Asymptomatic pulmonary lesions on chest x-ray
- Uncontrollable high fever (greater than 39C)
- History of chest or ear surgery
- Congenital spherocytosis
- Any anemia or blood disorder
- Any convulsive disorder
- History of optic neuritis or sudden blindness
- Middle ear infection
- Diabetes mellitus (insulin therapy)
- The subject is pregnant or lactating
- Nicotine use/substance use/addiction
- Acute Hypoglycemia
- Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
- Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.
- Active malignancy
- Current manic, delusional, or psychotic episodes
- Serious/current suicidal ideations
- Severe or unstable physical disorders or major cognitive deficits
- Inability to attend scheduled clinic visits or comply with study protocols.
- Treated with HBOT for any reason prior to study enrollment.
- Non-English speakers
- History of retinal repair, including laser photocoagulation or retinal detachment surgery.
- History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.
- Age greater than 75 years.
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07214415
Start Date
October 1 2025
End Date
September 15 2026
Last Update
October 9 2025
Active Locations (1)
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1
Summit Hyperbarics and Wellness
Boise, Idaho, United States, 83716