Hyperbaric Oxygen Therapy for Veterans' Mental Health

Overseen By Troy Nickel, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Summit Hyperbarics and Wellness

Must not be taking: Anti-metabolites, Chemotherapy, Disulfiram, others

Disqualifiers: Diabetes, Nicotine use, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hyperbaric oxygen therapy (HBOT) can improve cognitive function, mental health, and quality of life in veterans with PTSD, depression, anxiety, or mild traumatic brain injury (mTBI). HBOT involves breathing pure oxygen in a pressurized room or chamber, which might aid healing and mental clarity. Veterans clinically diagnosed with these conditions who have already tried therapies like CBT or EMDR could be suitable candidates for this study. The goal is to assess HBOT's effectiveness for these challenges and its potential variations among different groups. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering veterans a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires that you stay stable on any current psychoactive medications, like antidepressants or anti-anxiety meds. However, you cannot use certain medications like anti-metabolites, chemotherapeutic agents, and some others during the study.

Is there any evidence suggesting that Hyperbaric Oxygen Therapy is likely to be safe for humans?

Research has shown that hyperbaric oxygen therapy (HBOT) might help veterans with mental health issues like PTSD. In one study, veterans who received HBOT reported improvements in mood, sleep, and anger management. This suggests that HBOT could enhance mental well-being.

Regarding safety, the FDA has approved HBOT for other conditions, such as wound healing and carbon monoxide poisoning, indicating that the treatment is generally safe. However, HBOT can sometimes cause minor side effects, like changes in ear pressure, similar to those experienced on an airplane.

Since this trial is in an early phase, safety remains a top priority and is closely monitored. Participants should discuss any concerns with the medical professionals involved in the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hyperbaric Oxygen Therapy (HBOT) is unique because it uses pure oxygen delivered in a pressurized chamber to boost oxygen levels in the brain, which can help improve mental health conditions like PTSD in veterans. Unlike standard treatments such as medication or talk therapy, HBOT directly enhances the brain's healing processes by increasing oxygen delivery, potentially leading to faster and more effective recovery. Researchers are excited about this therapy because it offers a novel approach that could complement or enhance existing treatments, providing new hope for those who haven't found relief with traditional methods.

What evidence suggests that Hyperbaric Oxygen Therapy might be an effective treatment for veterans' mental health?

Research has shown that Hyperbaric Oxygen Therapy (HBOT), which participants in this trial will receive, can improve mental health in veterans. Studies have found that HBOT significantly reduces symptoms of depression and PTSD in male veterans. Recipients of HBOT also reported better sleep and more effective anger management. Additionally, a thorough review found that HBOT led to reliable and meaningful improvements in these areas. Overall, evidence suggests that HBOT may enhance thinking skills, mental well-being, and quality of life in veterans. ^{2 5 6 7 8}

Who Is on the Research Team?

Steven Wyman, MD

Principal Investigator

Summit Hyperbarics and Wellness

Are You a Good Fit for This Trial?

This trial is for veterans who have experienced traumatic brain injuries or post-traumatic stress disorder. Participants should be interested in exploring the effects of Hyperbaric Oxygen Therapy on their mental health and cognitive functions.

Inclusion Criteria

Veteran status

Completed cognitive and psychological measurements

Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity

Exclusion Criteria

The subject is pregnant or lactating

Nicotine use/substance use/addiction

Current manic, delusional, or psychotic episodes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Hyperbaric Oxygen Therapy (HBOT) to evaluate its effects on cognitive functioning, PTSD, depression, anxiety, and quality of life

8 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The study tests if Hyperbaric Oxygen Therapy can improve veterans' cognitive abilities, psychological well-being, and overall quality of life. It measures changes before and after treatment while considering demographic factors.

How Is the Trial Designed?

Group I: HBOT Intervention Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Summit Hyperbarics and Wellness

Lead Sponsor

Citations

1. psychiatrist.com psychiatrist.com/jcp/hyperbaric-oxygen-therapy-controlled-trial-veterans-ptsd/

Hyperbaric Oxygen Therapy for Veterans With Combat ... Hyperbaric oxygen therapy demonstrated significant improvements on measures of depression in male veterans with combat-associated PTSD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10630921/

The use of hyperbaric oxygen for veterans with PTSD At 13 weeks, the participants who received HBOT showed improvement in post-concussive and PTSD symptoms, sleep quality, control of anger, and ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1360311/full

Systematic review and dosage analysis: hyperbaric oxygen ... Overall, the studies' data demonstrate that HBOT caused statistically significant, reliable change, or clinically meaningful change/improvements ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06581003

Hyperbaric Oxygen Treatment for Veterans with Traumatic ... How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2); Does HBOT reduce posttraumatic stress disorder (PTSD) ...

5. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no143&eBriefTitle=Hyperbaric+Oxygen+Therapy+for+TBI+and+PTSD

Hyperbaric Oxygen Therapy for TBI and PTSD An evidence brief on the use of hyperbaric oxygen therapy for the treatment of TBI, PTSD, or their co-occurrence.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07214415

Veterans' Cognitive Function, Mental Health, and Quality of ... The purpose of this study is to evaluate how hyperbaric oxygen therapy (HBOT) may affect cognitive functioning, post-traumatic stress disorder ( ...

7. psychiatrist.com psychiatrist.com/news/hyperbaric-oxygen-therapy-shows-promise-in-treating-ptsd/

Hyperbaric Oxygen Therapy Shows Promise in Treating ... Clinical relevance: New research shows that hyperbaric oxygen therapy could significantly reduce PTSD symptoms in veterans resistant to ...

8. usf.edu usf.edu/health/news/2025/veterans-powering-landmark-hyperbaric-oxygen-research.aspx

Veteran-led mission: Meet the service members powering ... If hyperbaric oxygen therapy proves effective, it could transform the standard of treatment for veterans with TBI and PTSD. If not, it will save ...