Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study

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.

Hyperbaric oxygen therapy (HBOT) for Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) - The aim of the current study is to evaluate the effect of HBOT on patients suffering for mild to moderate CFS. Patients will undergo a series of 60 HBOT over a span of 3 months, with a 3 month follow-up period. Patient's evaluation point includes the following tests: physical performance, questionnaires, cognitive tests, brain MRI, EEG, blood tests & muscle biopsy.

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