Hyperbaric Oxygen Therapy for Post-COVID Syndrome and Chronic Fatigue
Observational Study of Hyperbaric High Pressure Oxygen Therapy (HBOT) in Patients with Post-COVID Syndrome (PCS) and Myalgic Encephalomyelitis/chronic Fatigue Syndrome (ME/CFS)
This study is looking at how Hyperbaric Oxygen Therapy might help people with chronic fatigue after COVID and other infections feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06118138 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document symptom progression in 60 patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who will undergo Hyperbaric Oxygen Therapy (HBOT) following COVID or other infections. Participants will complete health evaluations, including questionnaires like the SF-36, to assess changes in ME/CFS-related symptoms after receiving HBOT. The focus is on observing and documenting these changes rather than evaluating the efficacy of HBOT itself, providing insights that could inform future randomized controlled trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with ME/CFS and have previously participated in the CFS_CARE study.
Not a fit: Patients with acute infections, severe medical conditions, or those unwilling to consent to data storage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into symptom management for patients suffering from ME/CFS and post-COVID syndrome.
How similar studies have performed: While the approach of using HBOT for ME/CFS is being explored, this specific observational study is novel and aims to document symptom progression rather than test efficacy.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Carmen Scheibenbogen, Prof. Dr. — Charite University, Berlin, Germany
- Study coordinator: Carmen Scheibenbogen, Prof. Dr.
- Email: fatigue-centrum@charite.de
- Phone: +49 (0)30 450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.