Hyperbaric Oxygen Therapy for ME/CFS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates the effects of hyperbaric oxygen therapy (HBOT) in adults with mild to moderate ME/CFS. Participants will receive 60 HBOT sessions over three months, followed by three months of observation, with assessments including physical performance, cognitive tests, questionnaires, brain MRI, EEG, and blood and muscle tests. A sham treatment arm is included to compare outcomes. The study aims to determine whether HBOT can improve symptoms and functional status in ME/CFS patients. Safety monitoring and adherence checks are incorporated throughout the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject willing and able to read, understand and sign an informed consent
* Diagnosis of mild to moderate severity of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
* Patients diagnosed with CFS for more than 1 years
* Stable psychological and pharmacological treatment for more than three months prior to inclusion

Exclusion Criteria:

1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. Severe and very severe cases of ME/CFS
3. History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases
4. Active malignancy
5. Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
6. Active smokers
7. Chronic heart failure with ejection fraction of 30 or less
8. Chest pathology incompatible with pressure changes (including active asthma or COPD)
9. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
10. Pregnancy
11. An inability to perform an awake brain MRI
12. An inability to perform Neurotrax
13. Participation in another medical study
14. HBOT for any reason prior to study enrolment

Where it's running

• The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
  Zrifin, Israel Recruiting

Study contacts

• Principal investigator: Eli Kravchik, MD — principle investigator
• Study coordinator: Eli Kravchik, MD
• Email: elikr@shamir.gov.il
• Phone: 089779241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.