NCT07621068 Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
| NCT ID | NCT07621068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assaf-Harofeh Medical Center |
| Condition | Chronic Fatigue Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-07-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2026-07-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the effects of hyperbaric oxygen therapy (HBOT) in patients with mild to moderate CFS/ME. Participants will undergo 60 HBOT sessions over 3 months with a 3-month follow-up, including physical, cognitive, imaging, and laboratory assessments.
Eligibility Criteria
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
Contact & Investigator
Eli Kravchik, MD
PRINCIPAL INVESTIGATOR
principle investigator
Frequently Asked Questions
Who can join the NCT07621068 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Fatigue Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07621068 currently recruiting?
Yes, NCT07621068 is actively recruiting participants. Contact the research team at elikr@shamir.gov.il for enrollment information.
Where is the NCT07621068 trial being conducted?
This trial is being conducted at Zrifin, Israel.
Who is sponsoring the NCT07621068 clinical trial?
NCT07621068 is sponsored by Assaf-Harofeh Medical Center. The principal investigator is Eli Kravchik, MD at principle investigator. The trial plans to enroll 74 participants.