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RECRUITING
NCT07621068
NA

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

Sponsor: Assaf-Harofeh Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-07-19

Completion Date

2027-06

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DEVICE

Hyperbaric oxygen therapy

60 consecutive sessions of breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.

DEVICE

SHAM treatment

60 consecutive sessions of breathing 21% oxygen by mask at 1 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.

Locations (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel