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Recruiting NCT07214415

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

Phase II Interventional TBI Traumatic Brain Injury PTSD - Post Traumatic Stress Disorder Post Concussive Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric Oxygen Therapy.
Who it may be relevant to
Registry conditions: TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Hyperbaric 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

Primary outcome measures

  • PTSD Checklist for DSM-5 (PCL-5) [Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session]
  • NeuroTrax [Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session]
  • Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session]
  • World Health Organization Quality of Life (WHOQOL-BREF) [Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Summit Hyperbarics and Wellness — Boise

Identifiers

NCT: NCT07214415 · HBOT-VET-2025-001 · 20253309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗