[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639749":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":50,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":25,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperbaric oxygen therapy","ACTIVE_COMPARATOR","Hyperbaric Oxygen Therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. Each session includes breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes.",[13],"Device: Hyperbaric oxygen therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Hyperbaric oxygen therapy","SHAM_COMPARATOR","SHAM therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.02 ATA for 90 minutes with 5-minute air breaks, every 20 minutes.",[19],"Device: SHAM treatment",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","60 consecutive sessions of breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"SHAM treatment","60 consecutive sessions of breathing 21% oxygen by mask at 1 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.",[15],[31],{"name":32,"affiliation":33,"role":34},"Eli Kravchik, MD","principle investigator","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","089779241","elikr@shamir.gov.il",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Shai Efrati, Prof","efratishai@outlook.com",[44],{"facility":45,"status":25,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)","Zrifin","70300","Israel","IL",{"type":34,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Eli Kravchik","Principal Investigator, MD","100639749","hyperbaric-oxygen-therapy-for-chronic-fatigue-syndrome-cfs-100639749",false,"NCT07621068","Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS)","Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study","Inclusion Criteria:\n\n* Subject willing and able to read, understand and sign an informed consent\n* Diagnosis of mild to moderate severity of Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome\n* Patients diagnosed with CFS for more than 1 years\n* Stable psychological and pharmacological treatment for more than three months prior to inclusion\n\nExclusion Criteria:\n\n1. Inability to attend scheduled clinic visits and\u002For comply with the study protocol\n2. Severe and very severe cases of ME\u002FCFS\n3. History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases\n4. Active malignancy\n5. Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture\n6. Active smokers\n7. Chronic heart failure with ejection fraction of 30 or less\n8. Chest pathology incompatible with pressure changes (including active asthma or COPD)\n9. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)\n10. Pregnancy\n11. An inability to perform an awake brain MRI\n12. An inability to perform Neurotrax\n13. Participation in another medical study\n14. HBOT for any reason prior to study enrolment","ALL","18 Years",{"count":63,"type":64},74,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study evaluates the effects of hyperbaric oxygen therapy (HBOT) in patients with mild to moderate CFS\u002FME. Participants will undergo 60 HBOT sessions over 3 months with a 3-month follow-up, including physical, cognitive, imaging, and laboratory assessments.",[70],"Chronic Fatigue Syndrome",[9,72],"Myalgic Encephalomyelitis","NOT_YET_RECRUITING","2026-05-27",{"date":76,"type":77},"2026-06-02","ACTUAL",{"date":79,"type":64},"2026-06",{"date":81,"type":64},"2027-06",{"name":5,"class":6},1]