TBI Traumatic Brain InjuryPhase 2NCT07214415
Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with TBI Traumatic Brain Injury and PTSD - Post Traumatic Stress Disorder, run by Summit Hyperbarics and Wellness at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans. 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive Syndrome
- What is being tested?
- Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 15 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Veteran status
- Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional.
- The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently.
- Exposed to at least one trauma-focused therapy or evidence-based psychotherapeutic treatment, such as prolonged exposure therapy, EMDR, or CBT, to name a few.
- Completed cognitive and psychological measurements.
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- Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
- 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 current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).
Who cannot join
- Untreated pneumothorax
- History of spontaneous pneumothorax
- Severe sinus infection
- Upper respiratory infection
- Asymptomatic pulmonary lesions on chest x-ray
- Uncontrollable high fever (greater than 39C)
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- 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 subject is pregnant or lactating
- Nicotine use/substance use/addiction
- Acute Hypoglycemia
- Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema
- Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds.
- Active malignancy
- Current manic, delusional, or psychotic episodes
- Serious/current suicidal ideations
- Severe or unstable physical disorders or major cognitive deficits
- Inability to attend scheduled clinic visits or comply with study protocols.
- Treated with HBOT for any reason prior to study enrollment.
- Non-English speakers
- History of retinal repair, including laser photocoagulation or retinal detachment surgery.
- History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement.
- Age greater than 75 years.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Summit Hyperbarics and Wellness
Boise, Idaho, 83716
Troy Nickel, PhD, 208-813-9541, tnickel@shwidaho.org
About this study
Official title: Evaluating the Effects of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
- Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores?
- To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.
- Conditions
- TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive Syndrome
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Brain Injuries, Traumatic, Combat Disorders, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDrug
Each HBOT session is scheduled for approximately 95 minutes. The session will begin with a descent of up to 15 minutes (longer if needed for comfort/safety) to a pressure of 2.0 ATA, followed by 30 minutes of breathing 100% oxygen. At the midpoint, there will be a 5-minute air break from oxygen, after which subjects resume breathing 100% oxygen for another 30 minutes. Finally, the session will conclude with an ascent of up to 15 minutes (longer if needed for comfort/safety) back to 1.0 ATA.
All sessions are delivered under direct medical supervision with standardized safety protocols. Once approved after medical and behavioral screening, participants complete a battery of cognitive, mental health, and quality of life assessments at baseline (pre-) and after completing the therapy (post-). This arm is distinct from any sham or control interventions because all participants receive the active HBOT treatment.
| Study group | Role | What they receive |
|---|---|---|
| HBOT Intervention Group | Experimental | Not described Receives: Drug: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Measured: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
NeuroTrax
A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.
Measured: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Measured: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Measured: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
World Health Organization Quality of Life (WHOQOL-BREF)
Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets
Measured: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Oct 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summit Hyperbarics and Wellness
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Wyman, Summit Hyperbarics and Wellness
- Investigators
- Steven Wyman, MD, Principal investigator, Summit Hyperbarics and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214415
- Sponsor's protocol ID
- HBOT-VET-2025-001
- Other IDs
- 20253309
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
- ClinicalTrials.gov ID
- NCT07214415
- Acronym / sponsor ID
- HBOT-VET-2025-001
- Conditions
- TBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Summit Hyperbarics and WellnessUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder (PTSD), depression, anxiety, and overall quality of life in veterans.
- Does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and quality of life among veterans, as measured by pre-and post-treatment scores?
- To what extent does Hyperbaric Oxygen Therapy improve cognitive functioning, psychological well-being, and qualify of life among veterans, after controlling for demographic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOT Intervention Group | Experimental | Drug: Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age.
- Veteran status
- Clinically diagnosed with a mTBI, PTSD, Anxiety, or Depression disorder by meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and by a qualified and trained professional.
- The subject is willing and able to read, understand, and sign an informed consent. Additionally, the subject has clear consciousness and the ability to express self-feelings independently.
- Exposed to at least one trauma-focused therapy or evidence-based psychotherapeutic treatment, such as prolonged exposure therapy, EMDR, or CBT, to name a few.
Key exclusion criteria (29 listed)
- Untreated pneumothorax
- History of spontaneous pneumothorax
- Severe sinus infection
- Upper respiratory infection
- Asymptomatic pulmonary lesions on chest x-ray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyEach HBOT session is scheduled for approximately 95 minutes. The session will begin with a descent of up to 15 minutes (longer if needed for comfort/safety) to a pressure of 2.0 ATA, followed by 30 minutes of breathing 100% oxygen. At the midpoint, there will be a 5-minute air break from oxygen, after which subjects resume breathing 100% oxygen for another 30 minutes. Finally, the session will conclude with an ascent of up to 15 minutes (longer if needed for comfort/safety) back to 1.0 ATA. All sessions are delivered under direct medical supervision with standardized safety protocols. Once approved after medical and behavioral screening, participants complete a battery of cognitive, mental health, and quality of life assessments at baseline (pre-) and after completing the therapy (post-). This arm is distinct from any sham or control interventions because all participants receive the active HBOT treatment. | Drug | HBOT Intervention Group |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to assess symptoms of PTSD
NeuroTrax
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session.
A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to assess depression severity
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to measure anxiety severity
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session
Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal belief domains and facets
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for TBI Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Wyman, MD principal investigator
Summit Hyperbarics and Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with TBI Traumatic Brain Injury and PTSD - Post Traumatic Stress Disorder, run by Summit Hyperbarics and Wellness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Troy Nickel, PhD (208-813-9541, tnickel@shwidaho.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.