Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Israel
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
RECRUITING
Zrifin
Contact Information
Primary
Eli Kravchik, MD
elikr@shamir.gov.il
089779241
Backup
Shai Efrati, Prof
efratishai@outlook.com
Time Frame
Start Date: 2026-07-19
Estimated Completion Date: 2027-06
Participants
Target number of participants: 74
Treatments
Active_comparator: Hyperbaric oxygen therapy
Hyperbaric Oxygen Therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. Each session includes breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes.
Sham_comparator: Sham Hyperbaric oxygen therapy
SHAM therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.02 ATA for 90 minutes with 5-minute air breaks, every 20 minutes.
Related Therapeutic Areas
Sponsors
Leads: Assaf-Harofeh Medical Center