[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502669":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":23,"centralContacts":27,"locations":32,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":10,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Maastricht University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"COPD and\u002For emphysema",null,"COPD is defined according to COPD Gold 2023 guidelines. Emphysema defined acording to Fleischner criteria (2024)",[13,14],"Other: voice sampling","Other: capnometry",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"voice sampling","Patients with COPD will perform several voice-related tasks and capnometry at rest. Thereafter a 5-STS will follow and the voice-related task\u002Fcapnometry will be repeated",[9],{"type":6,"name":21,"description":18,"armGroupLabels":22,"otherNames":10},"capnometry",[9],[24],{"name":25,"affiliation":5,"role":26},"Sami Simons, MD PhD","PRINCIPAL_INVESTIGATOR",[28],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+31 043 3876543","sami.simons@mumc.nl",[33,50],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Dept of Respiratory Medicine, Maastricht University Medical Centre","RECRUITING","Maastricht","Limburg","6202 AZ","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],5.68889,50.84833,{"lat":45,"lon":44},[48],{"name":25,"role":29,"phone":49,"phoneExt":10,"email":31},"+31433876543",{"facility":51,"status":52,"city":53,"state":37,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Laurentius Ziekenhuis","NOT_YET_RECRUITING","Roermond","6043 CV",{"type":42,"coordinates":56},[57,58],5.9875,51.19417,{"lat":58,"lon":57},[61,65,66],{"name":62,"role":29,"phone":63,"phoneExt":10,"email":64},"Ragnar Lunde, MD","+31-(0)475 382 222","r.lunde@lzr.nl",{"name":10,"role":29,"phone":63,"phoneExt":10,"email":10},{"name":67,"role":68,"phone":10,"phoneExt":10,"email":10},"Martijn Cuijpers, Msc","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[72],{"name":73,"class":74},"Roche Pharma AG","INDUSTRY","100502669","exploring-novel-biomarkers-for-emphysema-detection-100502669",false,"NCT05825261","Exploring Novel Biomarkers for Emphysema Detection","Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study","ENBED","Inclusion Criteria:\n\n* Adults aged over 18 years\n* current respiratory smptoms (any dyspnea, cough or sputum)\n* spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second\u002FForced Vital Capacity (FEV1\u002FFVC ratio) \\\u003C 0.7 and\u002For emphysemateus abnormalities on CT imaging.\n* presence of risk factors or causes associated with COPD\n* chest CT scan performed in the past 12 months prior to inclusion to the study\n* able to understand, read and write Dutch language\n\nExclusion Criteria:\n\n* acute exacerbation of COPD within 8 weeks of start of the study\n* comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA\\\u003C BMI \\> 40)\n* comorbidities affecting speech characteristics of dyspnea (severe heart failure, interstitial lung disease)\n* comorbidities affecting respiratory system including but not exclusive to asthma or cystic fibrosis\n* comorbidities that significantly interfere with interpretation of speech (audio signals), such as Parkinson's disease, bulbar palsy, or vocal cord paralysis.\n* Medical history of lobectomy or endoscopic lung volume reduction (ELVR)\n* inability to carry out a capnography recording.\n* investigator's uncertainty about the willingness or ability of the patients to comply with the protocol requirements.\n* participation in another study involving investigational products. Participation in observational studies is allowed.","ALL","18 Years",{"count":86,"type":87},200,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:\n\n• Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and\u002For capnometry.\n\nParticipants will:\n\n* perform different voice-related tasks\n* perform capnometry twice (before\u002Fafter exercise)\n* perform a light exercise task between tasks ( 5-sit-to-stand test)\n* undergo one venipuncture",[91,92],"Copd","Emphysema",[94,95,96,21,97],"vocal biomarkers","speech","emphysema","chest CT","2025-06-10",{"date":100,"type":101},"2025-06-13","ACTUAL",{"date":103,"type":101},"2023-09-07",{"date":105,"type":87},"2026-05",{"name":5,"class":6},2]