Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized 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. 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who miss a substantial number of treatments (five consecutively or one-third of the total treatments) will be withdrawn from the study.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.

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

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).

Sponsors & Collaborators

• Medical Corps, Israel Defense Force

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• Israel

Study Locations