An interventional study of Hyperbaric Oxygen Therapy in PTSD - Post Traumatic Stress Disorder, sponsored by Medical Corps, Israel Defense Force. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Medical Corps, Israel Defense Force · Not applicable, Interventional, and Treatment
Post-traumatic stress disorder (PTSD), affecting approximately 6% of the general population and up to one-third of individuals exposed to combat zones and disasters, is a significant contributor to morbidity and mortality among IDF personnel. Hyperbaric oxygen therapy (HBOT), in which patients breathe oxygen at a partial pressure higher than 1 atmosphere in a hyperbaric chamber, has been investigated in the context of treating a wide range of neuropsychiatric disorders, including PTSD and mild traumatic brain injury (mTBI).
Four controlled studies conducted in patients with mTBI, about half of whom also suffered from PTSD, have yielded conflicting conclusions regarding the potential efficacy of hyperbaric therapy. A single study involving approximately 30 patients with PTSD without mTBI demonstrated significant clinical improvement; however, it was characterized by several methodological limitations-chief among them the absence of blinding or a placebo control. None of the studies conducted to date have reported long-term findings (beyond one year), included patients with a short duration of symptoms ("early PTSD"), or included female participants.
The aim of the proposed study is to conduct a prospective, double-blind, controlled investigation of the biological effect of hyperbaric therapy in PTSD, continuously throughout the hyperbaric treatment course, at the end of treatment, and during a substantial follow-up period of two years after treatment completion.
We intend to include adult participants who are capable of providing informed consent and who meet DSM-5 diagnostic criteria for PTSD. In order to maintain a pragmatic study with high external validity, exclusion criteria will be limited to those indicating risk (concrete suicidality, or a history of manic or psychotic disorder) or factors likely to impair treatment efficacy (incompatibility with hyperbaric chamber treatment, inability to complete the full treatment protocol, or pregnancy). Participants who miss a substantial number of treatments (five consecutively or one-third of the total treatments) will be withdrawn from the study.
The primary outcome measure will be the CAPS-5 questionnaire. In addition, PTSD symptom questionnaires, surveys assessing cognitive, executive, affective functioning, and health-related quality of life will be administered. An exploratory outcome will focus on sleep quantity and quality and physiological monitoring using wearable devices, currently considered the most promising biomarker in the context of PTSD.
Following enrollment and the provision of informed consent, balanced randomization will be performed with respect to covariates previously described as potential confounders (such as age, duration, and severity of symptoms, …). Participants will receive 60 hyperbaric treatments, five days per week, at either 2.0 atmospheres or 2.5 atmospheres. Both the participants and the evaluating clinical staff will be blinded to treatment allocation.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 72 is close to the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment will be carried out in a HAUX STARMED multi-place pressure chamber (by HAUX LIFESUPPORT SYSTEMS, Cuxhaven, Germany) containing three sections (12+2+6 places, respectively). Ambulatory blood pressure measurement will be performed by an ambulatory blood pressure monitor (ABPM) model F11 (by SUNTECH). Measurement of sleep continuity and physiological monitoring will be performed using a combined pulse-oxymetry and accelerometry wearable device such as the Oura ring (Oulu. Finland).
Procedure: Hyperbaric Oxygen Therapy
The treatment will be carried out in a HAUX STARMED multi-place pressure chamber (by HAUX LIFESUPPORT SYSTEMS, Cuxhaven, Germany) containing three sections (12+2+6 places, respectively). Ambulatory blood pressure measurement will be performed by an ambulatory blood pressure monitor (ABPM) model F11 (by SUNTECH). Measurement of sleep continuity and physiological monitoring will be performed using a combined pulse-oxymetry and accelerometry wearable device such as the Oura ring (Oulu. Finland).
Procedure: Hyperbaric Oxygen Therapy
The treatment will be carried out in a HAUX STARMED multi-place pressure chamber (by HAUX LIFESUPPORT SYSTEMS, Cuxhaven, Germany) containing three sections (12+2+6 places, respectively). Ambulatory blood pressure measurement will be performed by an ambulatory blood pressure monitor (ABPM) model F11 (by SUNTECH). Measurement of sleep continuity and physiological monitoring will be performed using a combined pulse-oxymetry and accelerometry wearable device such as the Oura ring (Oulu. Finland).
Primary Outcome
The change in the Clinician-Administered PTSD Scale (CAPS)-5 score at the end of the treatment series compared to the baseline score
Time frame: 12 weeks
Secondary Outcome
The change in the CAPS-5 score two years after inclusion in the study relative to the baseline score
Time frame: 12 weeks
Secondary Outcome
Changes in the Beck's Depression Inventory (BDI) score
Time frame: 12 weeks
Secondary Outcome
Changes in the score of the Pittsburgh Sleep Quality Questionnaire (PSQ)
Time frame: 12 weeks
Secondary Outcome
Changes in the State Trait Anxiety questionnaire score
Time frame: 12 weeks
Secondary Outcome
Changes in the post-traumatic disorder score in the CAPS-5 continuously over time
Time frame: 12 weeks
Secondary Outcome
Changes in the Basic Symptoms Inventory (BSI)
Time frame: 12 weeks
Secondary Outcome
Changes in Executive Function Questionnaire (BRIEF-A)
Time frame: 12 weeks
Exploratory Outcomes
Sleep continuity index
Time frame: 12 weeks
Exploratory Outcomes
Average blood pressure while awake and asleep over 24 hours
Time frame: 12 weeks
Exploratory Outcomes
Psychomotor Vigilance Test (PVT)
Time frame: 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Start is estimated for Mar 2026; primary completion for Aug 2027, 17 months later.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 17 months is below that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Medical Corps, Israel Defense Force