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

NCT06118138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Post-COVID ME/CFS

Interventions

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.

Sponsors & Collaborators

  • KLINIK BAVARIA Kreischa

    collaborator UNKNOWN

  • Vivantes Klinikum im Friedrichshain

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Carmen Scheibenbogen, Prof. Dr. · Charite University, Berlin, Germany

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06118138 on ClinicalTrials.gov