Traumatic Brain InjuryPhase 2NCT07852728
HBOT Effects on First Responders' Cognition and Well-Being
A Phase 2 study testing Hyperbaric Oxygen Therapy (HBOT) in people with Traumatic Brain Injury and PTSD - Post Traumatic Stress Disorder, run by Summit Hyperbarics and Wellness at 1 site in United States.
Trial summary
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Anxiety
- What is being tested?
- Hyperbaric Oxygen Therapy (HBOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2026to 11 Sep 2027
- 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
- Adults aged 18 to 75 years.
- Current or former first responder.
- Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional.
- Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes.
- Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document.
- Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures.
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- Presence of clinically significant symptoms resulting in functional impairment in occupational, social, or other key 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.
- Stable regimen of psychoactive medications (if applicable), including antidepressants, anxiolytics, antipsychotics, stimulants, and mood stabilizers, for a clinically appropriate stabilization period prior to enrollment, as determined by the study physician.
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 participant 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, Ph.D., 208-813-9541, tnickel@shwidaho.org
Steve Wyman, MD
About this study
Official title: Changes in Cognitive Functioning, Psychological Well-Being, and Quality of Life Following Hyperbaric Oxygen Therapy in First Responders
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:
- Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions?
- Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment?
Read more
Approximately 54 participants will:
- Complete medical and behavioral health screening.
- Complete cognitive tests and questionnaires before and after treatment.
- Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions.
All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.
Read the detailed description
This prospective, single-arm study will examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in approximately 54 current or former first responders with a history of traumatic brain injury (TBI). Secondary outcomes include symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety, as well as quality of life.
After providing informed consent, participants will undergo medical and behavioral health screening to determine eligibility for HBOT. Eligible participants will complete baseline cognitive testing and questionnaires measuring post-concussive symptoms, psychological symptoms, and quality of life. These assessments will be repeated after treatment.
Participants will receive 40 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 take place twice daily, Monday through Friday, with at least four hours between sessions. A physician will prescribe and oversee treatment, and trained hyperbaric personnel will operate the chamber and monitor participants.
Changes between baseline and post-treatment assessments will be analyzed within participants. The study will also explore whether demographic or clinical characteristics are associated with the magnitude of change. All participants will receive HBOT; there is no randomized or untreated comparison group. As a result, the study can describe changes observed following treatment but cannot establish that HBOT caused those changes.
- Conditions
- Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Anxiety, Depression, Post Concussion Symptoms
- Being tested
- Hyperbaric Oxygen Therapy (HBOT)
- Keywords
- First responders, Traumatic Brain Injury (TBI), Post Concussion Symptoms, Hyperbaric Oxygen Therapy (HBOT), Cognitive Functioning, Post-traumatic stress disorder (PTSD), Depression, Anxiety, Quality of Life
- Medical subject headings
- Brain Injuries, Traumatic, Combat Disorders, Anxiety Disorders, Depression, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy (HBOT)Drug
Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment. Receives: Drug: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NeuroTrax Global Cognitive Score
Change in Global Cognitive Score from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Change in post-concussive symptom score from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Secondary outcomes (4)
Change in PTSD Checklist for DSM-5 (PCL-5) score
Change in PTSD symptom score from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Patient Health Questionnaire-9 (PHQ-9) score
Change in depression symptom score from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Change in anxiety symptom score from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores
Change in quality-of-life scores from baseline to completion of 40 HBOT sessions.
Measured: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start11 Sep 2026
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Hyperbaric Oxygen Therapy (HBOT): Participants will receive 40 sessions in a multiplace hyperbaric chamber 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 will occur twice daily, Monday through Friday, with at least four hours between sessions.
- 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
- Steve Wyman, MD, Principal investigator, Summit Hyperbarics and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852728
- Sponsor's protocol ID
- HBOT-FR-2026-001
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share IPD outside the study team. Given the relatively small sample of first responders and the sensitive clinical and occupational information collected, sharing participant-level data could increase the risk of re-identification. Study findings will be reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cognitive Functioning, Psychological Well-Being, and Quality of Life Following Hyperbaric Oxygen Therapy in First Responders
- ClinicalTrials.gov ID
- NCT07852728
- Acronym / sponsor ID
- HBOT-FR-2026-001
- Conditions
- Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Anxiety, Depression, Post Concussion Symptoms
- Keywords
- First responders, Traumatic Brain Injury (TBI), Post Concussion Symptoms, Hyperbaric Oxygen Therapy (HBOT), Cognitive Functioning, Post-traumatic stress disorder (PTSD), Depression, Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Summit Hyperbarics and WellnessUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 1 Oct 2026 (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 goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:
- Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions?
- Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment?
Approximately 54 participants will:
- Complete medical and behavioral health screening.
- Complete cognitive tests and questionnaires before and after treatment.
- Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions.
All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.
Detailed description
This prospective, single-arm study will examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in approximately 54 current or former first responders with a history of traumatic brain injury (TBI). Secondary outcomes include symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety, as well as quality of life.
After providing informed consent, participants will undergo medical and behavioral health screening to determine eligibility for HBOT. Eligible participants will complete baseline cognitive testing and questionnaires measuring post-concussive symptoms, psychological symptoms, and quality of life. These assessments will be repeated after treatment.
Participants will receive 40 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 take place twice daily, Monday through Friday, with at least four hours between sessions. A physician will prescribe and oversee treatment, and trained hyperbaric personnel will operate the chamber and monitor participants.
Changes between baseline and post-treatment assessments will be analyzed within participants. The study will also explore whether demographic or clinical characteristics are associated with the magnitude of change. All participants will receive HBOT; there is no randomized or untreated comparison group. As a result, the study can describe changes observed following treatment but cannot establish that HBOT caused those changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hyperbaric Oxygen Therapy (HBOT): Participants will receive 40 sessions in a multiplace hyperbaric chamber 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 will occur twice daily, Monday through Friday, with at least four hours between sessions.
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Drug: Hyperbaric Oxygen Therapy (HBOT)Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 to 75 years.
- Current or former first responder.
- Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional.
- Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes.
- Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document.
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 Therapy (HBOT)Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment. | Drug | Hyperbaric Oxygen Therapy |
Primary outcome
Change in NeuroTrax Global Cognitive Score
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Global Cognitive Score from baseline to completion of 40 HBOT sessions.
Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in post-concussive symptom score from baseline to completion of 40 HBOT sessions.
4 secondary outcomes
Change in PTSD Checklist for DSM-5 (PCL-5) score
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores
Time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).
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 1 Oct 2026.
- Individual participant dataSharing planned: No. There is no current plan to share IPD outside the study team. Given the relatively small sample of first responders and the sensitive clinical and occupational information collected, sharing participant-level data could increase the risk of re-identification. Study findings will be reported in aggregate.
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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.
Steve 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 (HBOT) in people with 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 1 Oct 2026. 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, Ph.D. (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?
Change in NeuroTrax Global Cognitive Score (time frame: Baseline and after completion of 40 HBOT sessions (approximately 4 weeks).). The study lists 2 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 1 Oct 2026.