HBOT in Post-COVID and ME/CFS: Prospective Observational Study at Charité (NCT06118138)

What is it about? Charité is conducting a prospective cohort study that documents the course of symptoms in 60 patients with ME/CFS (following COVID or other infections) who receive hyperbaric oxygen therapy (HBOT) as a complementary treatment. The aim is not to prove efficacy, but to systematically collect longitudinal results to serve as a basis for future randomized controlled trials (RCTs). Study Design & Protocol Design & Recruitment Study type: Prospective, non-interventional, observational (cohort) Target sample: n=60 (age 18–65), already included in CFS_CARE; ME/CFS diagnosis according to CCC (incl. post-exertional malaise ≥14 h) Location: Charité – Universitätsmedizin Berlin (in collaboration with Klinik Bavaria Kreischa and others) HBOT framework (clinical routine) Pressure: 2 ATA, 100% O₂, 90 min/session, with 5-minute air breaks every 20 min Frequency/Duration: 5×/week for 8 weeks (planned 20–40 treatment days depending on individual course) Safety: Standard monitoring; main hazards are pressure-related, O₂ toxicity is rare Assessment schedule Baseline ~Week 4 after HBOT start 4 weeks after HBOT completion Follow-up every 2 months until 12 months after treatment Data collection via REDCap questionnaires and clinic visits. Endpoints Primary endpoint Clinically relevant improvement in physical function (SF-36 Physical Function/PF) ≥ +10 points 4 weeks after HBOT (scale 0–100; higher = better) Important secondary endpoints Chalder Fatigue Scale (physical/mental) Bell Disability Scale (0–100) MBSQ (Munich Berlin Symptom Questionnaire; 44 symptoms, 8 domains) Hand grip strength (HGS) NASA 10-Minute Lean Test (orthostatic tolerance) 1-Minute Sit-to-Stand Test (exercise capacity) Tolerance (questionnaire at the end of HBOT) Why is this important? Post-COVID and ME/CFS are often associated with endothelial dysfunction, hypoperfusion, fatigue, and cognitive impairment. HBOT has the potential to improve tissue oxygenation and microcirculation and promote angiogenesis. Previous studies on Long-COVID (pilot, RCT) and ME/CFS suggest possible benefits. This study aims to capture real-world courses and refine criteria for future RCTs. Inclusion & Exclusion (excerpt) Inclusion: Age 18–65 ME/CFS diagnosis (CCC) Bell score 30–70 Planned HBOT course of 20/40 days Declaration of consent Exclusion: Missing data consent Pregnancy Relevant HBOT risks (e.g. severe heart/lung disease) Acute infection Context & Outlook Character: Observational – no proof of efficacy, but dense longitudinal data with patient-relevant outcomes (SF-36 PF, fatigue, function) Aim: Identification of clinically significant response thresholds and sustained effects → basis for interventional RCTs (e.g. dosage, duration, subgroups with endothelial dysfunction)