NCT07732374 · Summit Hyperbarics and Wellness
Long-Term Outcomes Following HBOT
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Hyperbaric Oxygen Therapy (HBOT)
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Where
- Boise, Idaho
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations