Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
Part of paid clinical trials in Boise, Idaho.
- Sponsor
- Summit Hyperbarics and Wellness
- Study ID
- NCT07849465
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- PTSD
- Post Concussive Symptoms
- Traumatic Brain Injury (TBI) Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Hyperbaric Oxygen Therapy (HBOT) — DRUGHyperbaric 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.
Study Details
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.
Key Dates
- First listed
- Sep 30, 2026
- Start date
- Oct 1, 2026
- Status verified
- Sep 2026
- Primary completion
- Oct 1, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 34 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Hyperbaric Oxygen Therapy (HBOT) - 40 SessionsParticipants 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.
Primary Outcome Measure
Change in blood C-reactive protein (CRP) concentration [ Time Frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). ]
Central Contacts
- Troy Nickel, Ph.D.208-813-9541
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Summit Hyperbarics and Wellness | Boise | Idaho | 83716 |
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