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

What is it about?

Charité is conducting a prospective cohort study documenting the symptom trajectory of 60 patients with ME/CFS (following COVID or other infections) who receive hyperbaric oxygen therapy (HBOT) as an adjunct treatment. The aim is not to demonstrate efficacy but to systematically capture longitudinal outcomes 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 (ages 18–65), already enrolled 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-min 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 risks are pressure-related, O₂-toxicity is rare

Assessment Timeline

• Baseline

• ~Week 4 after HBOT start

• 4 weeks after HBOT completion

• Every 2 months follow-up up to 12 months post-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 at 4 weeks post-HBOT (scale 0–100; higher = better)

Key secondary endpoints

• Chalder Fatigue Scale (physical/mental)

• Bell Disability Scale (0–100)

• MBSQ (Munich Berlin Symptom Questionnaire; 44 symptoms, 8 domains)

• Handgrip strength (HGS)

• NASA 10-Minute Lean Test (orthostatic tolerance)

• 1-Minute Sit-to-Stand Test (exercise capacity)

• Tolerability (questionnaire at end of HBOT)

Why is this important?

Post-COVID and ME/CFS are frequently associated with endothelial dysfunction, hypoperfusion, fatigue, and cognitive impairment. HBOT has the potential to enhance tissue oxygenation and microcirculation, while promoting angiogenesis. Previous studies in Long-COVID (pilot, RCT) and ME/CFS suggest possible benefits. This study aims to capture real-world trajectories 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

• Informed consent

Exclusion:

• Missing data consent

• Pregnancy

• Relevant HBOT risks (e.g., severe cardiac/pulmonary disease)

• Acute infection

Context & Outlook

• Character: Observational—no efficacy proof, but dense longitudinal data with patient-relevant outcomes (SF-36 PF, fatigue, function)

• Goal: Identify clinically meaningful responder thresholds and sustained effects → foundation for interventional RCTs (e.g., dosage, duration, subgroups with endothelial dysfunction)