Recruiting
Phase 2

HBOT

Sponsor:

Summit Hyperbarics and Wellness

Code:

NCT07849465

Conditions

Traumatic Brain Injury (TBI) Patients

Post Concussive Symptoms

PTSD

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 blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are:

1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS?
2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?

Participants will:

Complete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions.

Approximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.

Conditions

Traumatic Brain Injury (TBI) Patients

Post Concussive Symptoms

PTSD

Study ID

NCT07849465

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 18 years of age.
2. Veteran status
3. Clinically diagnosed with a TBI by a qualified healthcare professional.
4. Participants with comorbid post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria by a qualified and trained professional, are eligible for enrollment but are not required for study participation.

4\. The participant is willing and able to read, understand, and sign an informed consent. Additionally, the participant has clear consciousness and the ability to express self-feelings independently.

6\. Completed psychological measurements (pre-study screening requirement) 7. Presence of clinically significant cognitive and/or PCS symptoms resulting in impairment in occupational, social, and other important 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\. Stability on any prescribed psychoactive medications and/or other chronic medical medications. Stability is defined as no significant changes in type of dosage within the previous 4-5 weeks, to minimize confounding effects on study outcomes and ensure participant safety.

Exclusion Criteria:

1. Untreated pneumothorax
2. History of spontaneous pneumothorax
3. Asymptomatic pulmonary lesions on chest x-ray
4. Uncontrollable high fever (greater than 39C)
5. History of chest or ear surgery
6. Congenital spherocytosis
7. Any anemia or blood disorder
8. Any convulsive disorder
9. History of optic neuritis or sudden blindness
10. Middle ear infection
11. Diabetes mellitus (insulin therapy)
12. The participant is pregnant or lactating
13. Nicotine use/substance use/addiction
14. Acute Hypoglycemia
15. Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
16. Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.
17. Active malignancy
18. Current manic, delusional, or psychotic episodes
19. Serious/current suicidal ideations
20. Severe or unstable physical disorders or major cognitive deficits
21. Inability to attend scheduled clinic visits or comply with study protocols.
22. Treated with HBOT for any reason prior to study enrollment.
23. Non-English speakers
24. History of retinal repair, including laser photocoagulation or retinal detachment surgery.
25. History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.
26. Age greater than 75 years.
27. Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapeutic 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.
28. Recent vaccination (≤ 1 week), or underlying inflammatory conditions
29. Use of systemic corticosteroids or immunomodulatory therapies
30. Active or recent infection requiring antibiotics.
31. Significant renal or hepatic impairment.
32. Regular participation in intense physical training or exercise programs (Defined as endurance events (e.g., triathlons, marathons, ultramarathons, Ironman-level training) or high-intensity interval training (HIIT) programs performed multiple times per week)
33. Recent (within 4 weeks prior to baseline) or planned use of antioxidant supplements or high-dose vitamins (Examples include: Vitamin C (> 500 mg/day), Vitamin E (>200 IU/day), N-acetylcysteine (NAC) or other thiol-based antioxidants, Alpha-lipoic acid, high-dose multivitamins containing the above doses, or Omega-3 fatty acid concentrates taken specifically for antioxidant/anti-inflammatory purposes)
34. Recent participation in other clinical trials that could affect biomarker levels.
35. Untreated or severe sleep disorders

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyperbaric Oxygen Therapy (HBOT) - 40 Sessions

Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). Each session will include two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions.

Interventions

Hyperbaric Oxygen Therapy (HBOT)

Hyperbaric Oxygen Therapy (HBOT): Participants will complete 40 sessions at 2.0 atmospheres absolute (ATA). Each session includes two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions are generally scheduled twice daily with at least four hours between them.

Primary outcome measure

  • Change in blood C-reactive protein (CRP) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood interleukin-1 (IL-1) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood interleukin-6 (IL-6) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood interleukin-10 (IL-10) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood tumor necrosis factor-alpha (TNF-α) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood brain-derived neurotrophic factor (BDNF) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood neurofilament light chain (NfL) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood glial fibrillary acidic protein (GFAP) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks) ]
  • Change in blood brain-derived tau (BD-tau) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
  • Change in blood ubiquitin C-terminal hydrolase L1 (UCH-L1) concentration [ 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

More Information

Sponsor

Summit Hyperbarics and Wellness

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Traumatic brain injury (TBI)
  • Post-concussive symptoms (PCS)
  • Post-traumatic stress disorder
  • Veterans
  • Hyperbaric Oxygen Therapy (HBOT)
  • Blood biomarkers
  • Neuroinflammation
  • Neuronal Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Summit Hyperbarics and Wellness on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.