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RECRUITINGOBSERVATIONAL

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

Observational Study of Hyperbaric High Pressure Oxygen Therapy (HBOT) in Patients with Post-COVID Syndrome (PCS) and Myalgic Encephalomyelitis/chronic Fatigue Syndrome (ME/CFS)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 Hyperbaric Oxygen Therapy (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 Hyperbaric Oxygen Therapy (HBOT) (e.g., heart failure, pulmonary disease, major depression, panic attacks) * Acute infection (e.g., COVID, HIV, or hepatitis)

Treatments Being Tested

COMBINATION_PRODUCT

Hyperbaric oxygen therapy (HBOT)

HBOT is a medical treatment employed for various conditions. It entails breathing 100% oxygen within a pressurized chamber known as a hyperbaric chamber. This oxygen-rich environment promotes healing and aids in combating specific infections. In this study, the investigators will administer HBOT using a hyperbaric chamber set to 2 times the normal atmospheric pressure, indicated as 2 atmosphere absolute (ATA). This pressure surge enhances oxygen dissolution into the bloodstream, surpassing levels achievable at sea level. The pressure will be raised incrementally, followed by HBOT sessions lasting for a total of 90 minutes. The 90-minute sessions include brief 5-minute intervals for ambient air every 20 minutes to ensure safety and comfort. Treatment will be conducted five days a week over eight weeks. Supervised by competent healthcare professionals, HBOT is considered safe, with potential side effects primarily stemming from heightened pressure and, in rare cases, oxygen toxicity.

Locations (1)

Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany