RecruitingPhase 2NCT07214415

Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy

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

Sponsor

Summit Hyperbarics and Wellness

Enrollment

54 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder TBI (Traumatic Brain Injury)Post Concussive Syndrome

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria29

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.

Interventions

DRUGHyperbaric 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.