[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617344":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":24,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent hypoxia-hyperoxia treatment (IHHT)","ACTIVE_COMPARATOR","An individualized treatment is administered to patients in 4-7 intervals, within 22-40 minutes. Blood oxygen saturation (O2-Sat) rises and falls cyclically, due to fluctuating fractions of inspired oxygen (FiO2): 9-13% in the hypoxic phase and 36% in the hyperoxic restitution phase.",[13],"Other: Intermittent hypoxia-hyperoxia treatment (IHHT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham treatment","PLACEBO_COMPARATOR","The placebo group will undergo 'sham treatment' with air breathing at 21% FiO2. To equate the sensation of IHHT, airbrakes will be simulated similar to the IHHT intervals in the treatment protocol.",[19],"Device: Placebo",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"The apparatus used to deliver the IHHT is the HypoxBreath machine (TUR GmbH, Rostock, Germany, CE Medical device class IIa). The HypoxBreath machine is constructed with a built-in compressor, an air reservoir, and a set of membranes, making it possible for the machine to either add or remove oxygen from the atmospheric air, thus delivering a dynamic FiO2 (fraction of inspired oxygen). The individualized therapy settings are regulated via the attached user interface. It is connected to a desk monitor and a data-collecting server.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DEVICE","Placebo","The placebo group will undergo 'sham treatment' with air breathing at 21% FiO2. To equate the sensation of oxygen therapy, airbrakes will be simulated similar to the oxygen therapy intervals in the treatment protocol.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Rikke KJ Olsen","CONTACT","+45 61262471","rikke.olsen@clin.au.dk",{"name":37,"role":33,"phone":38,"phoneExt":24,"email":39},"Mastaneh Nochi","+45 50559530","nochi@clin.au.dk",[41],{"facility":42,"status":24,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Aarhus University","Aarhus","Region Midt","8200","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],10.21076,56.15674,{"lat":52,"lon":51},[55,58],{"name":56,"role":33,"phone":57,"phoneExt":24,"email":35},"Rikke KJ Olsen, PhD","+4561262471",{"name":59,"role":33,"phone":24,"phoneExt":24,"email":24},"English",{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[63],{"name":64,"class":65},"Independent Research Fund Denmark","INDUSTRY","100617344","investigating-the-effects-of-intermittent-hypoxia-hyperoxia-treatment-ihht-in-people-with-myalgic-encephalomyelitischronic-fatigue-syndrome-mecfs-to-improve-fatigue-pain-and-quality-of-life-by-targeting-mitochondrial-dysfunction-and-autonomic-nervous-system-impairment-100617344",false,"NCT07317401","Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) to Improve Fatigue, Pain, and Quality of Life by Targeting Mitochondrial Dysfunction and Autonomic Nervous System Impairment","REenergizeME: Oxygen Therapy (OT) as a Novel Treatment for Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)","REenergizeME","ME\u002FCFS Patients\n\nInclusion Criteria:\n\n* Female sex\n* Age 20-59 years\n* Established diagnosis of Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) according to the International Consensus Criteria (ICC)\n* Disease duration \\>6 months\n* Presence of post-exertional malaise (PEM)\n* Mild or moderate disease severity according to NICE guidelines\n* Body mass index (BMI) \\>18 and \\\u003C30 kg\u002Fm²\n* Ability and willingness to attend study visits and complete the intervention protocol\n* Provision of written informed consent\n* Willingness to comply with all study procedures and restrictions throughout the study period\n* Use of highly effective contraception during study participation for women of childbearing potential\n\nExclusion Criteria:\n\n* Severe ME\u002FCFS according to NICE guidelines\n* Participation in another clinical trial that may interfere with the present study\n* Pregnancy, planned pregnancy, or breastfeeding\n* Presence of clinically significant psychiatric disease not considered part of ME\u002FCFS and likely to interfere with study participation or interpretation of results\n* Presence of clinically significant neurological disease, peripheral nerve disorder, or other neurological dysfunction not considered part of ME\u002FCFS\n* Active internal disease or clinically significant cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease that may interfere with study participation or interpretation of outcomes\n* Obstructive lung disease\n* Claustrophobia\n* History of spontaneous pneumothorax\n* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with IHHT\n* Chronic pain conditions not considered part of ME\u002FCFS and likely to interfere with assessments\n* Current structured graded exercise therapy (GET) or structured exercise programme\n* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes\n* Inability to comply with study procedures or communicate meaningfully with study personnel\n* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity\n\nHealthy Controls\n\nInclusion Criteria:\n\n* Female sex\n* Age 20-59 years\n* Body mass index (BMI) \\>18 and \\\u003C30 kg\u002Fm²\n* Ability and willingness to attend study visits\n* Provision of written informed consent\n* Good general health without clinically significant chronic medical, neurological, psychiatric, or pain conditions\n* Activity level and BMI broadly matched to ME\u002FCFS participants\n* Willingness to comply with all study procedures and restrictions throughout the study period\n* Use of highly effective contraception during study participation for women of childbearing potential\n\nExclusion Criteria:\n\n* Current or previous diagnosis of ME\u002FCFS\n* Participation in another clinical trial that may interfere with the present study\n* Pregnancy, planned pregnancy, or breastfeeding\n* Presence of clinically significant psychiatric, neurological, cardiovascular, pulmonary, metabolic, renal, hepatic, endocrine, or systemic disease\n* Chronic pain conditions, migraine disorder, or recurrent headache\u002Fback pain likely to interfere with study assessments\n* Obstructive lung disease\n* Claustrophobia\n* History of spontaneous pneumothorax\n* Presence of implanted medical devices, prostheses, or other conditions considered incompatible with study procedures\n* Current structured exercise programme or recent major change in exercise habits\n* Significant alcohol, tobacco, or cannabis use considered likely to interfere with study participation or interpretation of outcomes\n* Inability to comply with study procedures or communicate meaningfully with study personnel\n* Any condition which, in the opinion of the investigator, may compromise participant safety or study integrity",true,"FEMALE","20 Years","59 Years",{"count":79,"type":80},104,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study is testing a new treatment for people with Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) and long-term symptoms after COVID-19. Both conditions cause extreme fatigue, muscle pain, \"brain fog,\" and trouble concentrating, which often get worse after physical or mental activity. Currently, no effective treatments are available.\n\nThe treatment being studied is called Intermittent Hypoxia-Hyperoxia Treatment (IHHT). It uses a machine called HypoxBreath to deliver short cycles of low oxygen (hypoxia) and high oxygen (hyperoxia) through a mask. Each session lasts 22-40 minutes and is carefully monitored to track oxygen levels, heart rate, and breathing. The therapy is customized for each patient to ensure comfort and effectiveness. IHHT is believed to help the body adapt to oxygen-related stress, improving energy production and reducing inflammation.\n\nIn this trial, 104 patients with ME\u002FCFS will be randomly assigned to receive either IHHT or a placebo treatment with normal oxygen levels over eight weeks. The placebo group will follow a similar procedure without oxygen changes. An additional 20 healthy individuals will be recruited as a comparison group, but they will not undergo the treatment.\n\nParticipants will have medical check-ups before and after treatment to evaluate changes in fatigue, mental sharpness, pain, autonomic nervous system function, and overall quality of life. Blood samples and small skin biopsies will also be taken to study the biological processes behind ME\u002FCFS and how the treatment works.\n\nThis research aims to find out if IHHT can improve the lives of people with ME\u002FCFS or long-term COVID symptoms. The results could also provide new insights into the causes of these challenging conditions and guide future treatments.",[86],"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) (ICD-10 G93.3)","NOT_YET_RECRUITING","2026-05-20",{"date":90,"type":91},"2026-05-22","ACTUAL",{"date":93,"type":80},"2026-06-01",{"date":95,"type":80},"2029-01-01",{"name":5,"class":6},1]