Recruiting
Phase 2

HBOT

Sponsor:

Summit Hyperbarics and Wellness

Code:

NCT07852728

Conditions

Traumatic Brain Injury

PTSD - Post Traumatic Stress Disorder

Anxiety

Depression

Post Concussion Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen Therapy (HBOT)

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

PTSD - Post Traumatic Stress Disorder

Anxiety

Depression

Post Concussion Symptoms

Study ID

NCT07852728

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Sep 11, 2027

Anticipated

Primary completion date

Sep 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyperbaric Oxygen Therapy

Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment.

Interventions

Hyperbaric Oxygen Therapy (HBOT)

Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment.

Primary outcome measure

  • Change in NeuroTrax Global Cognitive Score [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]

Central Contacts and Locations

Central contacts

Locations

Summit Hyperbarics and Wellness

Recruiting

Boise, Idaho, United States, 83716

Contacts

Principal Investigator:

Steve Wyman, MD

More Information

Sponsor

Summit Hyperbarics and Wellness

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • First responders
  • Traumatic Brain Injury (TBI)
  • Post Concussion Symptoms
  • Hyperbaric Oxygen Therapy (HBOT)
  • Cognitive Functioning
  • Post-traumatic stress disorder (PTSD)
  • Depression
  • Anxiety
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Summit Hyperbarics and Wellness on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.