{"id":1657,"date":"2025-10-15T13:57:57","date_gmt":"2025-10-15T11:57:57","guid":{"rendered":"https:\/\/stv-electronic.mp-wd.de\/hbot-in-post-covid-and-me-cfs-prospective-observational-study-at-charite-nct06118138\/"},"modified":"2026-01-22T18:41:12","modified_gmt":"2026-01-22T17:41:12","slug":"hbot-in-post-covid-and-me-cfs-prospective-observational-study-at-charite-nct06118138","status":"publish","type":"post","link":"https:\/\/www.stv-electronic.de\/en\/hbot-in-post-covid-and-me-cfs-prospective-observational-study-at-charite-nct06118138\/","title":{"rendered":"HBOT in Post-COVID and ME\/CFS: Prospective Observational Study at Charit\u00e9 (NCT06118138)"},"content":{"rendered":"\n[et_pb_section fb_built=”1″ _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]What is it about?\nCharit\u00e9 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). \n\nStudy Design & Protocol\nDesign & Recruitment\n\nStudy type: Prospective, non-interventional, observational (cohort)\n\nTarget sample: n=60 (age 18\u201365), already included in CFS_CARE; ME\/CFS diagnosis according to CCC (incl. post-exertional malaise \u226514 h)\n\nLocation: Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin (in collaboration with Klinik Bavaria Kreischa and others)\n\nHBOT framework (clinical routine)\n\nPressure: 2 ATA, 100% O\u2082, 90 min\/session, with 5-minute air breaks every 20 min\n\nFrequency\/Duration: 5\u00d7\/week for 8 weeks (planned 20\u201340 treatment days depending on individual course)\n\nSafety: Standard monitoring; main hazards are pressure-related, O\u2082 toxicity is rare\n\nAssessment schedule\nBaseline\n\n~Week 4 after HBOT start\n\n4 weeks after HBOT completion\n\nFollow-up every 2 months until 12 months after treatment\n\nData collection via REDCap questionnaires and clinic visits.\n\nEndpoints\nPrimary endpoint\n\nClinically relevant improvement in physical function (SF-36 Physical Function\/PF) \u2265 +10 points 4 weeks after HBOT (scale 0\u2013100; higher = better)\n\nImportant secondary endpoints\n\nChalder Fatigue Scale (physical\/mental)\n\nBell Disability Scale (0\u2013100)\n\nMBSQ (Munich Berlin Symptom Questionnaire; 44 symptoms, 8 domains)\n\nHand grip strength (HGS)\n\nNASA 10-Minute Lean Test (orthostatic tolerance)\n\n1-Minute Sit-to-Stand Test (exercise capacity)\n\nTolerance (questionnaire at the end of HBOT)\n\nWhy is this important?\nPost-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. \n\nInclusion & Exclusion (excerpt)\nInclusion:\n\nAge 18\u201365\n\nME\/CFS diagnosis (CCC)\n\nBell score 30\u201370\n\nPlanned HBOT course of 20\/40 days\n\nDeclaration of consent\n\nExclusion:\n\nMissing data consent\n\nPregnancy\n\nRelevant HBOT risks (e.g. severe heart\/lung disease)\n\nAcute infection\n\nContext & Outlook\nCharacter: Observational \u2013 no proof of efficacy, but dense longitudinal data with patient-relevant outcomes (SF-36 PF, fatigue, function)\n\nAim: Identification of clinically significant response thresholds and sustained effects \u2192 basis for interventional RCTs (e.g. dosage, duration, subgroups with endothelial dysfunction)[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"

What is it about? Charit\u00e9 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 […]<\/p>\n","protected":false},"author":1,"featured_media":1654,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-1657","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nicht-kategorisiert"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/posts\/1657","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/comments?post=1657"}],"version-history":[{"count":0,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/posts\/1657\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/media\/1654"}],"wp:attachment":[{"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/media?parent=1657"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/categories?post=1657"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.stv-electronic.de\/en\/wp-json\/wp\/v2\/tags?post=1657"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}