Oxygen therapy under the microscope for chronic fatigue
NCT ID NCT06118138
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study watched 60 adults with ME/CFS (a condition causing severe fatigue) after they received hyperbaric oxygen therapy (HBOT) in a high-pressure chamber. Participants filled out health questionnaires to track changes in physical function and fatigue. The goal was not to prove HBOT works, but to gather information for future, more rigorous studies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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60 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Sixty male or female patients, aged between 18 and 65 years, will be included in the study. ME/CFS patients currently participating in the CFS\_CARE study through the Bavaria Clinic in Kreischa will have the opportunity to receive HBOT treatment as an additional option provided by the clinic upon completion of the CFS\_CARE study. Additionally, these patients will be invited to participate in this observational study during the final CFS\_CARE presentation at the 12-month mark.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 HBOT * Consent provided by the patient Exclusion Criteria: * 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 HBOT (e.g., heart failure, pulmonary disease, major depression, panic attacks) * Acute infection (e.g., COVID, HIV, or hepatitis)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
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