SWAlexander
Senior Member
- Messages
- 2,076
Trial description
Observational study aimed at assessing the improvement of physical function measured by the SF-36 after Hyperbaric Oxygen Therapy (HBOT) in patients with Post-COVID Syndrome and ME/CFSME/CFS is a widespread and profoundly debilitating condition. Those affected experience extreme fatigue, concentration difficulties, headaches, and other symptoms even with minimal physical and mental activity. ME/CFS is frequently observed even after COVID-19.
Current research suggests that Hyperbaric Oxygen Therapy (HBOT), currently being globally investigated as a therapeutic approach for Post-COVID Syndrome, could be an effective treatment. In two open-label studies and one placebo-controlled study, it was demonstrated that HBOT notably improved neurocognitive symptoms in Post-COVID patients. The presumed mechanism of action involves improving blood circulation, promoting capillary formation, and exerting a positive influence on the immune system function.
Based on this evidence, HBOT is already offered as a therapeutic procedure for Post-COVID Syndrome and ME/CFS in many centers in Germany for self-pay patients. The aim of our study is to investigate whether HBOT leads to long-term improvement in physical limitations in patients with ME/CFS.
HBOT will be administered on an outpatient basis, five days a week, over a period of 8 weeks in cooperation with the Vivantes Klinikum Friedrichshain. Treatment response will be assessed using questionnaires, measurements of muscle strength and cardiovascular function, as well as biomarkers.
A total of 60 participants will be enrolled in the study. Only patients who have previously participated in our observational studies can be included in the study. https://cfc.charite.de/en/clinical_research/nksg/trial_hbot/