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) — DRUG
    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.

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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Summit Hyperbarics and WellnessBoiseIdaho83716
Troy Nickel, Ph.D.
208-813-9541

Find similar trials in Boise, ID

Related Studies