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Hyperbaric High Pressure Oxygen Therapy in Post-COVID Syndrome and ME/CFS

CompletedN/A

Sponsor: Charite University, Berlin, Germany

Conditions: Post-COVID ME/CFS

Interventions: Hyperbaric oxygen therapy (HBOT)

Countries: Germany

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) following COVID or other infections. Participants will receive HBOT treatment as an additional option after completing the Chronic Fatigue Syndrome CARE (CFS\_CARE) study and will be invited to take part in this observational study. Patients will complete health evaluations in the form of questionnaires, including the 36-Item Short Form Health Survey (SF-36), to assess changes in ME/CFS-related symptoms after HBOT. Rather than evaluating the efficacy of HBOT itself, the study will focus on observing and documenting these changes. Its goal is to offer valuable insights into symptom progression in ME/CFS patients receiving HBOT, which can serve as a foundation for future interventional randomized controlled trials.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Locations (1)

Berlin, State of Berlin, Germany