PTSD - Post Traumatic Stress DisorderNCT07473362
Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized Trial
A study testing Hyperbaric Oxygen Therapy in people with PTSD - Post Traumatic Stress Disorder, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2026to 31 Aug 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Yarpa 112
Ramat Gan, Tel Aviv
Evan Gur, M.D, 0542555655, ostyly@gmail.com
About this study
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.
Read more
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.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- PTSD, HBO, Hyperbaric Oxygen Therapy
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 2.0 ata | Experimental | 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). Receives: Procedure: Hyperbaric Oxygen Therapy |
| 2.5 ata | Active comparator | 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). Receives: Procedure: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
Secondary Outcome
The change in the CAPS-5 score two years after inclusion in the study relative to the baseline score
Measured: 12 weeks
Secondary Outcome
Changes in the Beck's Depression Inventory (BDI) score
Measured: 12 weeks
Secondary Outcome
Changes in the score of the Pittsburgh Sleep Quality Questionnaire (PSQ)
Measured: 12 weeks
Secondary Outcome
Changes in the State Trait Anxiety questionnaire score
Measured: 12 weeks
Secondary Outcome
Changes in the post-traumatic disorder score in the CAPS-5 continuously over time
Measured: 12 weeks
Secondary Outcome
Changes in the Basic Symptoms Inventory (BSI)
Measured: 12 weeks
Secondary Outcome
Changes in Executive Function Questionnaire (BRIEF-A)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blinded, prospectively randomized, controlled, pragmatic study. The pragmatic design allowing for a myriad of additional therapy approaches, and in particular - stepping up or down pharmaco- and psycho- therapy during the trial, as well as widely applicable inclusion and exclusion criteria, aims to answer previous concerns raised of the external validity of contemporary clinical HBO research.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473362
- Sponsor's protocol ID
- 2436-2024
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
18. Doenyas-Barak K, Kutz I, Levi G, Lang E, Beberashvili I, Efrati S. Hyperbaric Oxygen Therapy for Veterans With Treatment-resistant PTSD: A Longitudinal Follow-up Study. Mil Med. 2023 Jul 22;188(7-8):e2227-33. 19. Doenyas-Barak K, Kutz I, Lang E, Levi G, Efrati S. Memory surfacing among veterans with PTSD receiving hyperbaric oxygen therapy. Undersea Hyperb Med. 2023;50(4):395-401. 20. Hoge CW, Jonas WB. The ritual of hyperbaric oxygen and lessons for the treatment of persistent postconcussion symptoms in military personnel. JAMA Intern Med. 2015 Jan;175(1):53-4. 21. Hart BB, Weaver LK, Gupta A, Wilson SH, Vijayarangan A, Deru K, et al. Hyperbaric oxygen for mTBI-associated PCS and PTSD: Pooled analysis of results from Department of Defense and other published studies. Undersea Hyperb Med. 2019;46(3):353-83. 22. Schimmel S, El Sayed B, Lockard G, Gordon J, Young I, D'Egidio F, et al. Identifying the target traumatic brain injury population for hyperbaric oxygen therapy. Int J Mol Sci. 2023 Sep 27;24(19). 23. Doenyas-Barak K, Kutz I, Lang E, Merzbach R, Lev Wiesel R, Boussi-Gross R, et al. The use of hyperbaric oxygen for veterans with PTSD: basic physiology and current available clinical data. Front Neurosci. 2023 Oct 25;17:1259473. 24. Bugni FA, Canay IA, Shaikh AM. Inference under Covariate-Adaptive Randomization. J Am Stat Assoc. 2018 Jun 28;113(524):1784-96. 25. Kang M, Ragan BG, Park J-H. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Jun;43(2):215-21. 26. Ma W, Ye X, Tu F, Hu F. carat : An R Package for Covariate-Adaptive Randomization in Clinical Trials. J Stat Softw. 2023;107(2). 27. Hart BB, Wilson SH, Churchill S, Deru K, Weaver LK, Minnakanti M, et al. Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019;46(3):313-27.
12. Jones MW, Brett K, Han N, Wyatt HA. Hyperbaric Physics. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. 13. Wolf EG, Prye J, Michaelson R, Brower G, Profenna L, Boneta O. Hyperbaric side effects in a traumatic brain injury randomized clinical trial. Undersea Hyperb Med. 2012 Dec;39(6):1075-82. 14. Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price RC, et al. Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial. Undersea Hyperb Med. 2018;45(2):129-56. 15. Miller RS, Weaver LK, Bahraini N, Churchill S, Price RC, Skiba V, et al. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. 2015 Jan;175(1):43-52. 16. Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. J Head Trauma Rehabil. 2014 Feb;29(1):11-20. 17. Doenyas-Barak K, Catalogna M, Kutz I, Levi G, Hadanny A, Tal S, et al. Hyperbaric oxygen therapy improves symptoms, brain's microstructure and functionality in veterans with treatment resistant post-traumatic stress disorder: A prospective, randomized, controlled trial. PLoS ONE. 2022 Feb 22;17(2):e0264161.
6. Davis LL, Schein J, Cloutier M, Gagnon-Sanschagrin P, Maitland J, Urganus A, et al. The economic burden of posttraumatic stress disorder in the united states from a societal perspective. J Clin Psychiatry. 2022 Apr 25;83(3). 7. Mayer Y, Shiffman N, Bergmann E, Natoor M, Khazen S, Lurie I, et al. Mental Health Outcomes of Arab and Jewish Populations in Israel a Month after the Mass Trauma Events of October 7, 2023: A Cross-Sectional Survey of a Representative Sample. Psychiatry Res. 2024 Jun 15;339:116042. 8. Lin C-C, Huang K-L, Tung C-S, Liu Y-P. Hyperbaric oxygen therapy restored traumatic stress-induced dysregulation of fear memory and related neurochemical abnormalities. Behav Brain Res. 2019 Feb 1;359:861-70. 9. Peng Y, Feng S-F, Wang Q, Wang H-N, Hou W-G, Xiong L, et al. Hyperbaric oxygen preconditioning ameliorates anxiety-like behavior and cognitive impairments via upregulation of thioredoxin reductases in stressed rats. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Aug 16;34(6):1018-25. 10. Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, et al. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. 11. Harch PG, Andrews SR, Rowe CJ, Lischka JR, Townsend MH, Yu Q, et al. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. Med Gas Res. 2020;10(1):8-20.
1. Parr NJ, Anderson J, Veazie S. Evidence Brief: Hyperbaric Oxygen Therapy for Traumatic Brain Injury and/or Post-traumatic Stress Disorder. Washington (DC): Department of Veterans Affairs (US); 2021. 2. Andrews SR, Harch PG. Systematic review and dosage analysis: hyperbaric oxygen therapy efficacy in the treatment of posttraumatic stress disorder. Front Neurol. 2024 May 31;15:1360311. 3. Mozayeni BR, Duncan W, Zant E, Love TL, Beckman RL, Stoller KP. The National Brain Injury Rescue and Rehabilitation Study - a multicenter observational study of hyperbaric oxygen for mild traumatic brain injury with post-concussive symptoms. Med Gas Res. 2019;9(1):1-12. 4. Harch PG. Systematic review and dosage analysis: hyperbaric oxygen therapy efficacy in mild traumatic brain injury persistent postconcussion syndrome. Front Neurol. 2022 Mar 17;13:815056. 5. Bennett MH. Evidence brief: hyperbaric oxygen therapy (HBOT) for traumatic brain injury and/or post-traumatic stress disorder. Diving Hyperb Med. 2018 Jun 30;48(2):115.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT07473362
- Acronym / sponsor ID
- 2436-2024
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, HBO, Hyperbaric Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double blinded, prospectively randomized, controlled, pragmatic study. The pragmatic design allowing for a myriad of additional therapy approaches, and in particular - stepping up or down pharmaco- and psycho- therapy during the trial, as well as widely applicable inclusion and exclusion criteria, aims to answer previous concerns raised of the external validity of contemporary clinical HBO research.
| Arm | Type | Receives |
|---|---|---|
| 2.0 ata | Experimental | Procedure: Hyperbaric Oxygen TherapyThe 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). |
| 2.5 ata | Active comparator | Procedure: Hyperbaric Oxygen TherapyThe 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 TherapyThe 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 or surgery | 2.0 ata, 2.5 ata |
Primary outcome
Primary Outcome
Time frame: 12 weeks
The change in the Clinician-Administered PTSD Scale (CAPS)-5 score at the end of the treatment series compared to the baseline score
7 secondary outcomes
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
Secondary Outcome
Time frame: 12 weeks
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 16 Mar 2026.
- Background18. Doenyas-Barak K, Kutz I, Levi G, Lang E, Beberashvili I, Efrati S. Hyperbaric Oxygen Therapy for Veterans With Treatment-resistant PTSD: A Longitudinal Follow-up Study. Mil Med. 2023 Jul 22;188(7-8):e2227-33. 19. Doenyas-Barak K, Kutz I, Lang E, Levi G, Efrati S. Memory surfacing among veterans with PTSD receiving hyperbaric oxygen therapy. Undersea Hyperb Med. 2023;50(4):395-401. 20. Hoge CW, Jonas WB. The ritual of hyperbaric oxygen and lessons for the treatment of persistent postconcussion symptoms in military personnel. JAMA Intern Med. 2015 Jan;175(1):53-4. 21. Hart BB, Weaver LK, Gupta A, Wilson SH, Vijayarangan A, Deru K, et al. Hyperbaric oxygen for mTBI-associated PCS and PTSD: Pooled analysis of results from Department of Defense and other published studies. Undersea Hyperb Med. 2019;46(3):353-83. 22. Schimmel S, El Sayed B, Lockard G, Gordon J, Young I, D'Egidio F, et al. Identifying the target traumatic brain injury population for hyperbaric oxygen therapy. Int J Mol Sci. 2023 Sep 27;24(19). 23. Doenyas-Barak K, Kutz I, Lang E, Merzbach R, Lev Wiesel R, Boussi-Gross R, et al. The use of hyperbaric oxygen for veterans with PTSD: basic physiology and current available clinical data. Front Neurosci. 2023 Oct 25;17:1259473. 24. Bugni FA, Canay IA, Shaikh AM. Inference under Covariate-Adaptive Randomization. J Am Stat Assoc. 2018 Jun 28;113(524):1784-96. 25. Kang M, Ragan BG, Park J-H. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Jun;43(2):215-21. 26. Ma W, Ye X, Tu F, Hu F. carat : An R Package for Covariate-Adaptive Randomization in Clinical Trials. J Stat Softw. 2023;107(2). 27. Hart BB, Wilson SH, Churchill S, Deru K, Weaver LK, Minnakanti M, et al. Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019;46(3):313-27.
- Background12. Jones MW, Brett K, Han N, Wyatt HA. Hyperbaric Physics. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023. 13. Wolf EG, Prye J, Michaelson R, Brower G, Profenna L, Boneta O. Hyperbaric side effects in a traumatic brain injury randomized clinical trial. Undersea Hyperb Med. 2012 Dec;39(6):1075-82. 14. Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price RC, et al. Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial. Undersea Hyperb Med. 2018;45(2):129-56. 15. Miller RS, Weaver LK, Bahraini N, Churchill S, Price RC, Skiba V, et al. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. 2015 Jan;175(1):43-52. 16. Cifu DX, Hart BB, West SL, Walker W, Carne W. The effect of hyperbaric oxygen on persistent postconcussion symptoms. J Head Trauma Rehabil. 2014 Feb;29(1):11-20. 17. Doenyas-Barak K, Catalogna M, Kutz I, Levi G, Hadanny A, Tal S, et al. Hyperbaric oxygen therapy improves symptoms, brain's microstructure and functionality in veterans with treatment resistant post-traumatic stress disorder: A prospective, randomized, controlled trial. PLoS ONE. 2022 Feb 22;17(2):e0264161.
- Background6. Davis LL, Schein J, Cloutier M, Gagnon-Sanschagrin P, Maitland J, Urganus A, et al. The economic burden of posttraumatic stress disorder in the united states from a societal perspective. J Clin Psychiatry. 2022 Apr 25;83(3). 7. Mayer Y, Shiffman N, Bergmann E, Natoor M, Khazen S, Lurie I, et al. Mental Health Outcomes of Arab and Jewish Populations in Israel a Month after the Mass Trauma Events of October 7, 2023: A Cross-Sectional Survey of a Representative Sample. Psychiatry Res. 2024 Jun 15;339:116042. 8. Lin C-C, Huang K-L, Tung C-S, Liu Y-P. Hyperbaric oxygen therapy restored traumatic stress-induced dysregulation of fear memory and related neurochemical abnormalities. Behav Brain Res. 2019 Feb 1;359:861-70. 9. Peng Y, Feng S-F, Wang Q, Wang H-N, Hou W-G, Xiong L, et al. Hyperbaric oxygen preconditioning ameliorates anxiety-like behavior and cognitive impairments via upregulation of thioredoxin reductases in stressed rats. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Aug 16;34(6):1018-25. 10. Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, et al. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. 11. Harch PG, Andrews SR, Rowe CJ, Lischka JR, Townsend MH, Yu Q, et al. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. Med Gas Res. 2020;10(1):8-20.
- Background1. Parr NJ, Anderson J, Veazie S. Evidence Brief: Hyperbaric Oxygen Therapy for Traumatic Brain Injury and/or Post-traumatic Stress Disorder. Washington (DC): Department of Veterans Affairs (US); 2021. 2. Andrews SR, Harch PG. Systematic review and dosage analysis: hyperbaric oxygen therapy efficacy in the treatment of posttraumatic stress disorder. Front Neurol. 2024 May 31;15:1360311. 3. Mozayeni BR, Duncan W, Zant E, Love TL, Beckman RL, Stoller KP. The National Brain Injury Rescue and Rehabilitation Study - a multicenter observational study of hyperbaric oxygen for mild traumatic brain injury with post-concussive symptoms. Med Gas Res. 2019;9(1):1-12. 4. Harch PG. Systematic review and dosage analysis: hyperbaric oxygen therapy efficacy in mild traumatic brain injury persistent postconcussion syndrome. Front Neurol. 2022 Mar 17;13:815056. 5. Bennett MH. Evidence brief: hyperbaric oxygen therapy (HBOT) for traumatic brain injury and/or post-traumatic stress disorder. Diving Hyperb Med. 2018 Jun 30;48(2):115.
- Individual participant dataSharing planned: Undecided
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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 study testing Hyperbaric Oxygen Therapy in people with PTSD - Post Traumatic Stress Disorder, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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 4 inclusion and 6 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 16 Mar 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 Israel. 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.
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 Evan Gur, M.D (0542555655, ostyly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473362, which also lists 4 linked publications.
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 16 Mar 2026.