Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder

NCT03466554 | Completed DMC

• 1 other identifier: 0199-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is the long term effect of severely distressing traumatic event characterized by intrusive thoughts, nightmares, and avoidance. Brain imaging of PTSD patients demonstrate alterations in regional brain perfusion, with stunned, hypoperfused regions. Those brain-biological pathologies may be responsible for the limited success rate of currently available interventions. During the last years data regarding Hyperbaric Oxygen Therapy (HBOT) induced neuroplasticity accumulated. A number of studies in traumatic brain injury, cerebrovascular attacks, and fibromyalgia have presented evidence of improved perfusion and recovery of metabolic brain tissues, accompanied by clinical improvement under HBOT even years after the acute insults. Considerable evidence supports potential benefit of HBOT on PTSD, however, no clinical trial was done on this pure PTSD population. The aim of the proposed study is to examine hyperbaric oxygen therapy as a treatment for PTSD. Advanced brain imaging and functional analysis tools will be used to evaluate treatment's effect.

Conditions

Ptsd

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms

  Symptoms assessed by the PTSD questionnaire (0-80)

  at baseline and after 3 months

Secondary Outcomes (5)

• Change in Sleep disorders questionnaire

  at baseline and after 3 months

• Change in Cognitive function

  at baseline and after 3 months

• Change in Brain imaging

  at baseline and after 3 months

• change in symptoms assessed by Diary for daily documentation of symptoms

  at baseline and after 3 months

• Change in Physiological evaluation of brain functionality

  at baseline and after 3 months

Study Arms (2)

hyperbaric oxygen therapy (HBOT) active treatment

EXPERIMENTAL

60 daily HBOT sessions will be administrated 5 days per week. Comprise of 90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes.

Device: Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes

Control-follow up

NO INTERVENTION

The standard of care of psychological and mediational support . After 3 months of follow up, participants will be re-evaluated. The individuals in the control group will then be offered to receive the treatment and to be re-reevaluated after the treatment is over (3 months).

Interventions

Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes DEVICE

60 daily HBOT sessions will be administrated 5 days per week. comprise of 90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes.

hyperbaric oxygen therapy (HBOT) active treatment

Eligibility Criteria

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

You may qualify if:

• Adult onset PTSD, defined by DSM-V criteria, as a result of combat or a terror- related event.
• Age 25-60 years, 4-years or more from the traumatic event and failure to improve with at least one line of conventional treatment.

You may not qualify if:

• A history of traumatic brain injury, epilepsy, a brain tumor; skull base fractures or neurosurgery.
• Severe substance use disorders a current manic episode, psychotic disorders or serious suicidal ideation at baseline.
• Major cognitive deficits
• History of HBOT for any reason, prior to study enrollment.
• Chest pathology incompatible with pressure changes (including active asthma).
• Inner ear disease.
• The inability to perform an awake brain MRI test.
• Inability to provide informed consent

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Shai a Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of segol center

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 15, 2018
• Study Start: March 4, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 20, 2019
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)