[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557380":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":12,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Politecnico di Milano","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","During oscillometry measures, the subject's cheeks are manually supported by an expert (Gold Standard method)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Cheek Holder","EXPERIMENTAL","During oscillometry measures, the subject's cheeks are supported by an integrated cheek support in the mouthpiece",[18],"Device: Mouthpiece with cheek-holder",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Mouthpiece with cheek-holder","A cheek support integrated into the mouthpiece is used for the measures",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Raffale Dellaca, PhD","CONTACT","0223999005","raffaele.dellaca@polimi.it",{"name":32,"role":28,"phone":33,"phoneExt":12,"email":34},"Chiara Veneroni, PhD","0223999024","chiara.veneroni@polimi.it",[36],{"facility":37,"status":38,"city":39,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Allergy and Pneumology Outpatient Clinic","RECRUITING","Bergamo","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],9.66721,45.69601,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":12,"phoneExt":12,"email":51},"Marcello Cottini","cottinimarcello@gmail.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Raffaele Dellaca","professor","100557380","mouthpiece-with-integrated-cheek-support-vs-manual-cheek-support-during-respiratory-oscillometry-100557380",false,"NCT06537362","Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry","Comparative Evaluation of the Use of a Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry Measurements","COMICUSROM","Inclusion Criteria:\n\n* subjects aged between 5 and 75 years\n\nExclusion Criteria:\n\n* Subjects unable to follow the study procedures or with any physical or mental condition deemed unsuitable by the doctor will be excluded from the study",true,"ALL","5 Years","75 Years",{"count":69,"type":70},55,"ESTIMATED","INTERVENTIONAL",[73],"NA","The study aims to evaluate the measurement accuracy of respiratory impedance during oscillometry (or Forced Oscillation Technique - FOT) under the following conditions: 1)The subject's cheeks are manually supported by an expert (Gold Standard method), 2) The subject's cheeks are supported by an integrated cheek support in the mouthpiece.\n\nIt is a prospective, randomized, cross-over study on Subjects who will present themselves at the offices of the participating doctors, aged between 5 and 75 years. The primary outcome is to Compare the respiratory impedance measurements under the two measurement conditions. Secondary Objectives are to: i)evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition; ii) assess the maximum and minimum face dimensions of the recruited subjects that allow for effective and comfortable cheek support; iii) evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece.",[76,77],"Respiratory Morbidity","Lung Function Decreased",[79],"Oscillometry","2024-08-26",{"date":82,"type":83},"2024-08-28","ACTUAL",{"date":85,"type":83},"2024-03-26",{"date":87,"type":70},"2024-08",{"name":5,"class":6},1]