Traumatic Brain InjuryPhase 2NCT07732374
Long-Term Outcomes Following HBOT
A Phase 2 study testing Hyperbaric Oxygen Therapy (HBOT) in people with Traumatic Brain Injury and Post-Concussive Symptoms, run by Summit Hyperbarics and Wellness at 1 site in United States.
Trial summary
This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress Disorder
- What is being tested?
- Hyperbaric Oxygen Therapy (HBOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 18 Jun 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 years and older
- 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, PCS, PTSD, Anxiety, or Depression disorder.
- Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).
- Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.
- Completed cognitive and psychological measurements.
- Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.
- Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).
Who cannot join
- Acute medical illness or infection
- Severe or unstable physical disorders or major cognitive deficits
- Current manic, psychotic episodes, or serious suicidal ideations
- Non-English speakers
- Inability to attend scheduled follow-up visits
- Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes.
- Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.
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
Steven Wyman, MD
About this study
Official title: Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.
Read the detailed description
This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended.
The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes.
The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status.
The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.
- Being tested
- Hyperbaric Oxygen Therapy (HBOT)
- Keywords
- Hyperbaric Oxygen Therapy, Treatment Durability, Cognitive Function, Mental Health, Quality of Life, Veterans, Traumatic Brain Injury, Persistent Post-Concussive Symptoms (PCS)
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy (HBOT)Drug
Also called Hyperbaric Oxygen, Hyperbaric Oxygen Treatment
Hyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| HBOT Follow-Up Cohort | Experimental | Veterans who previously completed a standardized Hyperbaric Oxygen Therapy (HBOT) treatment protocol and undergo follow-up assessments approximately 12 weeks after their final treatment session to evaluate the long-term durability of cognitive, psychological, and quality-of-life outcomes. Receives: Drug: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
PTSD Checklist for DSM-5 (PCL-5)
Self-report questionnaire to assess symptoms of PTSD
Measured: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Patient Health Questionnaire-9 (PHQ-9)
Self-report questionnaire to assess depression severity
Measured: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Generalized Anxiety Disorder 7-item scale (GAD-7)
Self-report questionnaire to measure anxiety severity
Measured: Baseline (post-HBOT completion) and 12 weeks after the 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, and environment facets
Measured: Baseline (post-HBOT completion) and 12 weeks after the 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 posted28 Jul 2026
- Study start18 Jun 2026
- Primary completion18 Jun 2027 (estimated)
- Study completion18 Jun 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
- This study utilizes a quasi-longitudinal design incorporating follow-up assessments to examine the sustained effects of Hyperbaric Oxygen Therapy (HBOT) on cognitive function, mental health, and quality of life in a cohort of veterans. Follow-up evaluations will employ validated cognitive and psychometric instruments to assess the durability of HBOT's therapeutic effects post-intervention. The post-treatment assessment is scheduled 12 weeks after each subject's final HBOT session.
- Masking
- None (open label)
- Enrolment
- 35 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732374
- Sponsor's protocol ID
- HBOT-VET-2026-002
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Given that our study involves a relatively small cohort of veterans and includes sensitive cognitive and mental health data, we selected "no" to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans
- ClinicalTrials.gov ID
- NCT07732374
- Acronym / sponsor ID
- HBOT-VET-2026-002
- Keywords
- Hyperbaric Oxygen Therapy, Treatment Durability, Cognitive Function, Mental Health, Quality of Life, Veterans, Traumatic Brain Injury, Persistent Post-Concussive Symptoms (PCS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Summit Hyperbarics and WellnessUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 28 Jul 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.
This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.
Detailed description
This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended.
The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes.
The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status.
The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a quasi-longitudinal design incorporating follow-up assessments to examine the sustained effects of Hyperbaric Oxygen Therapy (HBOT) on cognitive function, mental health, and quality of life in a cohort of veterans. Follow-up evaluations will employ validated cognitive and psychometric instruments to assess the durability of HBOT's therapeutic effects post-intervention. The post-treatment assessment is scheduled 12 weeks after each subject's final HBOT session.
| Arm | Type | Receives |
|---|---|---|
| HBOT Follow-Up Cohort | Experimental | Drug: Hyperbaric Oxygen Therapy (HBOT)Veterans who previously completed a standardized Hyperbaric Oxygen Therapy (HBOT) treatment protocol and undergo follow-up assessments approximately 12 weeks after their final treatment session to evaluate the long-term durability of cognitive, psychological, and quality-of-life outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age.
- Veteran status
- Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder.
- Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).
- Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.
Key exclusion criteria (7 listed)
- Acute medical illness or infection
- Severe or unstable physical disorders or major cognitive deficits
- Current manic, psychotic episodes, or serious suicidal ideations
- Non-English speakers
- Inability to attend scheduled follow-up visits
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)Also: Hyperbaric Oxygen, Hyperbaric Oxygen TreatmentHyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions. | Drug | HBOT Follow-Up Cohort |
Primary outcome
NeuroTrax
Time frame: Baseline (post-HBOT completion) and 12 weeks after the 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.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Self-report questionnaire to assess symptoms of PTSD
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Self-report questionnaire to assess depression severity
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline (post-HBOT completion) and 12 weeks after the final HBOT session
Self-report questionnaire to measure anxiety severity
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Baseline (post-HBOT completion) and 12 weeks after the 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, and environment 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 28 Jul 2026.
- Individual participant dataSharing planned: No. Given that our study involves a relatively small cohort of veterans and includes sensitive cognitive and mental health data, we selected "no" to share IPD with other researchers.
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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.
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 Post-Concussive Symptoms, 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 8 inclusion and 7 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 28 Jul 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, 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?
NeuroTrax (time frame: Baseline (post-HBOT completion) and 12 weeks after the 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 28 Jul 2026.