Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder

NCT04518007 | Completed DMC

• 1 other identifier: 291-19
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.

Conditions

Post Traumatic Stress Disorder

Keywords

hyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms

  PTSD symptoms will be assessed by the PTSD Clinician-Administered PTSD Scale (CAPS) questionnaire.

  Change from Baseline immediately after the intervention

Secondary Outcomes (13)

• depression

  Change from Baseline immediately after the intervention

• Changes in growth following a traumatic event

  Change from Baseline immediately after the intervention

• wellbeing

  Change from Baseline immediately after the intervention

• emotional regulation

  Change from Baseline immediately after the intervention

• global distress

  Change from Baseline immediately after the intervention

Study Arms (2)

hyperbaric oxygen therapy (HBOT) active treatment

ACTIVE COMPARATOR

The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes, of 100% oxygen at 2 ATA and 5-minute air breaks every 20 minutes.

Device: hyperbaric oxygen therapy

hyperbaric oxygen therapy (HBOT) sham treatment

SHAM COMPARATOR

All the conditions provided in the HBOT intervention will be provided in the sham intervention. However, in contrast to the HBOT, where the pressure will go up to 2 ATA, in the sham condition the pressure will go up to 1.1 ATA during the first five minutes of the session with noise of circulating air, and then decrease slowly during the next half hour to 1.0 ATA and the oxygen level will be 21% The initial 1.1 ATA level will provide a minimal pressure sensation in the ears, with the same nurse advice on pumping the ears. In the last five minutes of the session, the air will be circulated again with its related noises. Sham and HBOT sessions will never be adjacent, so subjects from the two groups cannot meet and discuss the session and its effects.

Device: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy DEVICE

The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sago l Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel.

hyperbaric oxygen therapy (HBOT) active treatment; hyperbaric oxygen therapy (HBOT) sham treatment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject willing and able to read, understand and sign an informed consent
• Age 25-60
• Five years or more after the last traumatic exposure
• CAPS-5 score PTSD symptoms questionnaire ≥ 20.
• Failure to improve after at least one line of conventional therapy, such as prolonged exposure, trauma related psychotherapy, eye movement desensitization therapy (EMDR).

You may not qualify if:

• Inability to attend scheduled clinic visits and/or comply with the study protocol.
• History of TBI or any other brain pathology
• Active malignancy
• Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
• Current manic episode or psychotic disorders
• Serious suicidal ideation
• Severe or unstable physical disorders or major cognitive deficits at baseline
• for any reason prior to study enrollment
• Chest pathology incompatible with pressure changes (including active asthma)
• Ear or Sinus pathology incompatible with pressure changes
• An inability to perform an awake brain MRI
• active smoking

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Dialysis Clinic in Asaf Harofhe Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (2)

• Danan D, Grosskopf Y, Mayo A, Efrati S, Kutz I, Lang E, Alon U, Doenyas-Barak K. Hyperbaric Oxygen Therapy for PTSD: Threshold Effect for Sustained Symptom Improvement in a Biologically Based Treatment. Brain Behav. 2025 Aug;15(8):e70757. doi: 10.1002/brb3.70757.

  PMID: 40847457 DERIVED

• Doenyas-Barak K, Kutz I, Lang E, Assouline A, Hadanny A, Aberg KC, Levi G, Beberashvili I, Mayo A, Efrati S. Hyperbaric Oxygen Therapy for Veterans With Combat-Associated Posttraumatic Stress Disorder: A Randomized, Sham-Controlled Clinical Trial. J Clin Psychiatry. 2024 Nov 10;85(4):24m15464. doi: 10.4088/JCP.24m15464.

  PMID: 39566051 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Keren Doenyas

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.1ATA, 21% oxygen)

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: August 19, 2020
• Study Start: February 25, 2020
• Primary Completion: January 26, 2024
• Study Completion: February 26, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)