NCT06118138Completed
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)
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 1 Nov 2023
- Start date
- 15 Jul 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06118138
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 15 Jul 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Unwillingness to consent to the storage of pseudonymized clinical data as a part of the study
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.