[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568823":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":34,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":34,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":93,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Sierra Varona SL","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypoxic-Hyperoxic group","EXPERIMENTAL","The EG (Experimental Group) will undergo a single session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 5 minutes, followed by 3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 6 cycles. During the hypoxic phase, oxygen saturation will be maintained between 85-92%, while during the hyperoxic phase, it will be kept above 95%. This process is regulated by the device's AI.\n\nParticipants will be asked to sit and breath normally in each exposure.\n\nAn attendance checklist will be used to monitor compliance with the intervention",[13],"Device: MITOVIT® Hypoxic Training System",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Hypoxic-Hyperoxic Group","SHAM_COMPARATOR","The Sham Group (SG) will follow a single session protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany).\n\nParticipants will be asked to sit and breath normally in each exposure.\n\nAn attendance checklist will be used to monitor compliance with the placebo intervention.",[19],"Device: Sham MITOVIT® Hypoxic Training System",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MITOVIT® Hypoxic Training System","The EG (Experimental Group) will undergo a single session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 5 minutes, followed by 3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 6 cycles. During the hypoxic phase, oxygen saturation will be maintained between 85-92%, while during the hyperoxic phase, it will be kept above 95%. This process is regulated by the device's AI. Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the intervention",[9],[27],"Hypoxic-Hyperoxic Exposure",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham MITOVIT® Hypoxic Training System","The Sham Group (SG) will follow a single session protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the placebo intervention.",[15],[33],"Sham Hypoxic-Hyperoxic Exposure",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Arturo Ladriñán","CONTACT","925 26 88 00","arturo.ladrinan@uclm.es",[42],{"facility":43,"status":34,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Residencial Montes de Toledo","Manzaneque","Toledo","45460","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],-3.79249,39.63549,{"lat":53,"lon":52},[56,57,59],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},{"name":37,"role":58,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":34,"phoneExt":34,"email":34},"Alberto Sánchez","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[65],{"name":66,"class":6},"Universidad Europea de Madrid","100568823","acute-effects-of-intermittent-hypoxia-hyperoxia-in-older-adults-100568823",false,"NCT06686238","Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults","Acute Effects of a Hypoxia-hyperoxia Exposure Session on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, and Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Being over 60 years old.\n* Having no previous experience in hypoxic training.\n* Engaging in less than 150 minutes of physical activity per week.\n\nExclusion Criteria:\n\n* Having any pathology that prevents the subject from being independent in terms of walking and functionality.\n* Subjects with impaired cognitive abilities.\n* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.\n* To have or have had cancer","ALL","65 Years","90 Years",{"count":78,"type":79},16,"ESTIMATED","INTERVENTIONAL",[82],"NA","The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.\n\nAccording to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, and arterial oxygen saturation.\n\nThe study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21%.",[85,86,87,88],"Older Adults","Cardiovascular Health","Blood Pressure","Sedentary",[90,91,92],"hypoxic exposure","older adults","heart rate variability","NOT_YET_RECRUITING","2024-11-25",{"date":96,"type":97},"2024-11-27","ACTUAL",{"date":99,"type":79},"2024-12-05",{"date":101,"type":79},"2024-12-26",{"name":5,"class":6},1]