Status:
RECRUITING
Hyperbaric High Pressure Oxygen Therapy in Post-COVID Syndrome and ME/CFS
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
KLINIK BAVARIA Kreischa
Vivantes Klinikum im Friedrichshain
Conditions:
Post-COVID ME/CFS
Eligibility:
All Genders
18-65 years
Brief Summary
The objective of this observational study is to document symptom progression in 60 patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who undergo Hyperbaric Oxygen Therapy (HBOT...
Detailed Description
Following mild to moderate COVID infection, around 10% of individuals develop post-COVID syndrome (PCS) characterized by symptoms like fatigue, exercise intolerance, cognitive impairment, headaches, a...
Eligibility Criteria
Inclusion
- Participants between the ages of 18 and 65 years who have previously participated in the CFS\_CARE study and have been diagnosed with ME/CFS
- ME/CFS diagnosis based on the Canadian Consensus Criteria (CCC), characterized by exercise intolerance and symptom worsening lasting for a minimum of 14 hours
- Disease severity determined by a Bell Score ranging from 30 to 70
- Plan to undergo 20 or 40 days of Hyperbaric Oxygen Therapy (HBOT)
- Consent provided by the patient
Exclusion
- Unwillingness to consent to the storage of pseudonymized clinical data as a part of the study
- Pregnancy
- Presence of medical conditions that could potentially pose a risk during Hyperbaric Oxygen Therapy (HBOT) (e.g., heart failure, pulmonary disease, major depression, panic attacks)
- Acute infection (e.g., COVID, HIV, or hepatitis)
Key Trial Info
Start Date :
July 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06118138
Start Date
July 15 2023
End Date
December 31 2025
Last Update
February 12 2025
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117