NCT07849465

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. 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. 2.Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
12mo left

Started Oct 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Oct 2027

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Traumatic Brain Injury (TBI) PatientsPost Concussive SymptomsPTSD

Keywords

Traumatic brain injury (TBI)Post-concussive symptoms (PCS)Post-traumatic stress disorderVeteransHyperbaric Oxygen Therapy (HBOT)Blood biomarkersNeuroinflammationNeuronal Injury

Outcome Measures

Primary Outcomes (10)

  • Change in blood C-reactive protein (CRP) concentration

    Difference in CRP concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood interleukin-1 (IL-1) concentration

    Difference in IL-1 concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood interleukin-6 (IL-6) concentration

    Difference in IL-6 concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood interleukin-10 (IL-10) concentration

    Difference in IL-10 concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood tumor necrosis factor-alpha (TNF-α) concentration

    Difference in TNF-α concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood brain-derived neurotrophic factor (BDNF) concentration

    Difference in BDNF concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood neurofilament light chain (NfL) concentration

    Difference in NfL concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood glial fibrillary acidic protein (GFAP) concentration

    Difference in GFAP concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks)

  • Change in blood brain-derived tau (BD-tau) concentration

    Difference in BD-tau concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

  • Change in blood ubiquitin C-terminal hydrolase L1 (UCH-L1) concentration

    Difference in UCH-L1 concentration between baseline and completion of 40 HBOT sessions.

    Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).

Study Arms (1)

Hyperbaric Oxygen Therapy (HBOT) - 40 Sessions

EXPERIMENTAL

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.

Drug: Hyperbaric Oxygen Therapy (HBOT)

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.

Hyperbaric Oxygen Therapy (HBOT) - 40 Sessions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age.
  • Veteran status
  • Clinically diagnosed with a TBI by a qualified healthcare professional.
  • 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.
  • \. 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.
  • \. 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.
  • \. 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.
  • \. 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.

You may not qualify if:

  • Untreated pneumothorax
  • History of spontaneous pneumothorax
  • Asymptomatic pulmonary lesions on chest x-ray
  • Uncontrollable high fever (greater than 39C)
  • History of chest or ear surgery
  • Congenital spherocytosis
  • Any anemia or blood disorder
  • Any convulsive disorder
  • History of optic neuritis or sudden blindness
  • Middle ear infection
  • Diabetes mellitus (insulin therapy)
  • The participant is pregnant or lactating
  • Nicotine use/substance use/addiction
  • Acute Hypoglycemia
  • Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summit Hyperbarics and Wellness

Boise, Idaho, 83716, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticPost-Concussion SyndromeStress Disorders, Post-TraumaticNeuroinflammatory Diseases

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain ConcussionHead Injuries, ClosedWounds, NonpenetratingStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Steve Wyman, MD

    Summit Hyperbarics and Wellness

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy Nickel, Ph.D.

CONTACT

208-813-9541tnickel@shwidaho.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is no current plan to share IPD with researchers outside the study team. Given the small study population and the combination of sensitive clinical and military service information collected, participant-level data sharing could increase the risk of re-identification. Study findings will be reported in aggregate.

Locations

US(1)