HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-arm interventional study enrolling about 54 adults who are current or former first responders with traumatic brain injury and persistent post-concussion symptoms. Participants will receive 40 HBOT sessions at 2.0 ATA, delivered twice daily on weekdays, with assessments of cognitive function, post-concussive symptoms, PTSD, depression, anxiety, and quality of life before and after treatment. The study uses within-subject comparisons to observe changes and explore whether demographic or clinical characteristics influence outcomes. There is no untreated control group, so causal attribution to HBOT cannot be established. A physician will oversee treatment in a multiplace chamber, with monitoring by hyperbaric personnel.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Adults aged 18 to 75 years.
2. Current or former first responder.
3. Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional.
4. Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes.
5. Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document.
6. Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures.
7. Presence of clinically significant symptoms resulting in functional impairment in occupational, social, or other key areas of functioning, as determined by clinical evaluation.
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. Stable regimen of psychoactive medications (if applicable), including antidepressants, anxiolytics, antipsychotics, stimulants, and mood stabilizers, for a clinically appropriate stabilization period prior to enrollment, as determined by the study physician.

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 participant 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 it's running

• Summit Hyperbarics and Wellness
  Boise, Idaho, United States Recruiting

Study contacts

• Principal investigator: Steve Wyman, MD — Summit Hyperbarics and Wellness
• Study coordinator: Troy Nickel, Ph.D.
• Email: tnickel@shwidaho.org
• Phone: 208-813-9541

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.