NCT07621068Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 19 May 2026
- Start date
- 19 Jul 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Assaf-Harofeh Medical Center
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07621068
What you commit to
- Study type: Interventional
- Planned participants: 74
- From 19 Jul 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- HBOT for any reason prior to study enrolment
Other illness
- History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases
- Active malignancy
Lab values
- Chronic heart failure with ejection fraction of 30 or less
Other
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Severe and very severe cases of ME/CFS
- Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
- Active smokers
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- Pregnancy
- An inability to perform an awake brain MRI
- An inability to perform Neurotrax
- Participation in another medical study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) Coordinator of this site? Confirm its status | Zrifin | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.