Hyperbaric oxygen therapy for post-traumatic stress disorder
Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized Trial
This will test whether breathing high-pressure oxygen in a chamber can help adults with PTSD who are eligible for discharge from military service.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical Corps, Israel Defense Force Academic / other |
| Locations | 1 site (Ramat Gan, Tel Aviv) |
| Trial ID | NCT07473362 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, double-blinded, randomized interventional trial testing hyperbaric oxygen therapy (HBOT) for PTSD. Participants are randomized to receive HBOT or a blinded sham in a hyperbaric chamber while breathing oxygen at a partial pressure above 1 atmosphere. The protocol requires a course of repeated treatments delivered five days per week, with clinical outcomes measured by changes in PTSD symptoms and functional status. The trial is conducted at the INMI facility in Ramat Gan, Israel, and includes efforts to enroll both men and women.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with a DSM-5 diagnosis of PTSD severe enough to warrant discharge from military service and who can commit to the full course of treatments.
Not a fit: People with current or past psychotic or manic disorders, active suicidal ideation, pregnancy, untreated pulmonary or ear pressure-equalization problems, or those unable to attend the required 120 sessions are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, HBOT could reduce PTSD symptoms and improve daily functioning for affected adults, offering an additional treatment option.
How similar studies have performed: Previous controlled trials in mTBI (with many participants also having PTSD) have produced mixed results, and a small unblinded PTSD-only study showed improvement but had major methodological limitations, so evidence is inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years and up to 80 years * Ability to understand the researcher's explanation and give informed consent. * Any sex or gender (unlike previous studies, a significant effort will be made to include women in this study) * A diagnosis of PTSD according to DSM-5 criteria with a severity that warrants discharge from military service. Exclusion Criteria: * The lack of ability to attend 120 daily (5 times/week) treatments at the INMI * Current or past psychotic disorder * Evidence of active suicidal ideation * Evidence of past or present manic disorder * Difficulty equalizing pressures, including pulmonary emphysema, significant sinusoidal obstruction, eustachian tube dysfunction, or an pneumothorax that is not drained. * Known or suspected pregnancy.
Where this trial is running
Ramat Gan, Tel Aviv
- Yarpa 112 — Ramat Gan, Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Evan Gur, M.D
- Email: ostyly@gmail.com
- Phone: 0542555655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.