Study of Hyperbaric Oxygen Therapy to Treat Post Traumatic Stress Disorder in Adults A Double-Blind, Randomized Controlled Trial with Long-Term Follow-Up

What this Trial Is About

Post-traumatic stress disorder PTSD affects about 6% of the general population and up to one-third of people exposed to combat or disasters, causing significant health challenges for affected individuals. Researchers are evaluating hyperbaric oxygen therapy HBOT, where patients breathe oxygen at higher-than-normal pressure inside a special chamber, to understand its biological effects on PTSD. This study is designed as a prospective, double-blind, controlled trial that includes adult participants meeting PTSD diagnostic criteria, aiming to assess treatment outcomes over two years following therapy. Participants will be randomly assigned to receive 60 sessions of hyperbaric oxygen therapy, five days a week, at either 2.0 or 2.5 atmospheres pressure. Treatments occur in a HAUX STARMED multi-place pressure chamber. Throughout the treatment and follow-up periods, participants will be monitored using ambulatory blood pressure devices and wearable technology that tracks sleep quality and physiological signals. The study includes a rigorous blinding process where neither the participants nor clinical staff know the assigned treatment pressure. During the study, participants will complete the CAPS-5 questionnaire as the primary outcome measure at 12 weeks. Additional assessments will evaluate PTSD symptoms, cognitive and emotional function, and quality of life. Physiological data related to sleep and other body functions will be collected using wearable devices. The study includes continuous monitoring during treatment and a substantial two-year follow-up period to understand long-term effects. Participants must be able to attend frequent treatments and assessments, and those missing significant sessions may be withdrawn from the study.

Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder - a Pragmatic, Double Blinded Randomized Trial