No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
Summit Hyperbarics and Wellness · Other
Who this trial is looking for
This trial is looking for current or former first responders who have experienced a traumatic brain injury and related symptoms. Participants will receive 40 sessions of hyperbaric oxygen therapy and complete some tests before and after treatment.
Are You a Good Fit for This Trial?
Rules you outActive malignancyChronic Obstructive Pulmonary Disease (COPD)Severe or unstable physical disordersSevere or unstable cognitive deficits
You may be able to join if
I am between 18 and 75 years old.
I am a current or former first responder.
I have been diagnosed with a traumatic brain injury.
I can provide informed consent.
I will complete required assessments before joining.
I have significant symptoms affecting my daily life.
I agree to use contraception if applicable.
I am stable on any psychoactive medications I take.
You may not be able to join if
I have untreated pneumothorax.
I have a severe sinus infection.
I have diabetes requiring insulin.
I am pregnant or breastfeeding.
I currently use nicotine or other addictive substances.
I have been treated with hyperbaric oxygen therapy before this study.
I have a serious current mental health issue.
I cannot attend clinic visits as required.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:
1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions?
2. Do symptoms of PTSD, depression, and anxiet…
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:
1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions?
2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment?
Approximately 54 participants will:
* Complete medical and behavioral health screening.
* Complete cognitive tests and questionnaires before and after treatment.
* Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions.
All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.
Trial Locations
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Status
Eligibility Criteria
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, depressi…
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.
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