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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Contact Information
Primary
Carmen Scheibenbogen, Prof. Dr.
fatigue-centrum@charite.de
+49 (0)30 450
Backup
Laura Kim
laura.kim@charite.de
Time Frame
Start Date: 2023-07-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Sponsors
Collaborators: Vivantes Klinikum im Friedrichshain, KLINIK BAVARIA Kreischa
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov