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RecruitingNCT07214415Updated Oct 9, 2025

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

A Phase 2 interventional study of Hyperbaric Oxygen Therapy in TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder and Post Concussive Syndrome, sponsored by Summit Hyperbarics and Wellness. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-09.

Sponsored by Summit Hyperbarics and Wellness · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • TBI Traumatic Brain Injury
  • PTSD - Post Traumatic Stress Disorder
  • Post Concussive Syndrome
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    HBOT Intervention Group

    Drug: Hyperbaric Oxygen Therapy

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.

05

What researchers measure

Primary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    Self-report questionnaire to assess symptoms of PTSD

    Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

  2. NeuroTrax

    A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.

    Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Self-report questionnaire to assess depression severity

    Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

  4. Generalized Anxiety Disorder 7-item scale (GAD-7)

    Self-report questionnaire to measure anxiety severity

    Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

  5. World Health Organization Quality of Life (WHOQOL-BREF)

    Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets

    Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session

06

Study locations

1 of 1 sites recruiting
  • Summit Hyperbarics and Wellness
    Boise, Idaho 83716, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07214415
Lead sponsor
Summit Hyperbarics and Wellness
Responsible party
Steve Wyman (Medical Director, Summit Hyperbarics and Wellness) — Principal investigator
First posted
Oct 9, 2025
Start date
Oct 1, 2025
Primary completion
Sep 15, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
Oct 9, 2025

Study contacts

Troy Nickel, PhD
Contact
tnickel@shwidaho.org
208-813-9541
Steven Wyman, MD
principal investigator · Summit Hyperbarics and Wellness

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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