Study Director: Prof. Dr. Carmen Scheibenbogen, Charité Berlin
Number of Participants: 60
Period: July 2023 - December 2025
This study observes how the symptoms of people with Post-COVID Syndrome (PCS) and ME/CFS change through Hyperbaric Oxygen Therapy (HBOT). The aim is not to prove definitive efficacy, but to document initial clinical observations as a basis for future controlled studies.
🧪 Participants receive HBOT as an additional offer upon completion of the CFS_CARE study. Over the course of 12 months, they regularly complete questionnaires to document progress in symptoms such as fatigue, cognitive issues, physical performance, and muscle strength.
"An increase of 10 points in the SF-36 physical function questionnaire is considered a clinically significant improvement."
→ This value serves as the primary objective of the study.
✅ HBOT is conducted with 2 ATA pressure (twice the atmospheric pressure), 5 days/week, over 8 weeks
✅ Safety assessment and tolerability are documented
✅ The therapy is performed on an outpatient basis, under medical supervision
The ME/CFS diagnosis of the participants is based on the Canadian Consensus Criteria, including typical symptoms such as post-exertional malaise (PEM), orthostatic intolerance, "brain fog," and sleep disturbances.
The study utilizes established questionnaires such as:
SF-36 (physical function)
Chalder Fatigue Scale
Bell Score (functional impairment)
MBSQ (symptom severity)
NASA Lean Test (circulatory response)
1-Minute Sit-to-Stand Test (endurance)
"Currently, there is no curative therapy for ME/CFS. This study aims to provide initial objective evidence on whether HBOT could be a viable therapeutic approach."
Not: to prove the causal effect of HBOT
But rather: systematically capture whether HBOT brings subjective and objective improvements – to develop a randomized controlled trial (RCT) based on that.
Study (PDF)
Study (PDF)
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