[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517220":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":92,"collaborators":94,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":19,"enrollmentInfo":116,"targetDuration":19,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":19,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Patients with swallowing disorders and healthy volunteers",[13],"Other: Swallowing evaluation",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Swallowing evaluation","For patients with swallowing disorders: assessment of the swallowing performed according to the available reference examination (videofluoroscopy or nasofibroscopy). In parallel, they will carry the following sensors: microphone, accelerometer, surface electromyography, nasal cannula and pulse oximeter. The subjects will also perform a cough and phonation test and questionnaires. Each subject (or his caregiver) will be contacted by phone once a month for 6 months to monitor the occurrence of complications. The end of study visit at 6 months will be done either at the hospital with a new examination of the swallowing, by telephone, as medically indicated.\n\nFor healthy volunteers: Only one visit is planned for the evaluation of the swallowing with the examination of nasofibroscopy and the installation of the sensors. The procedures (tests, examinations and questionnaires) will be identical to the data collection of the initial visit of patients with swallowing disorders)",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Virginie WOISARD, MD","University Hospital of Toulouse","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","33-567771718","woisard.v@chu-toulouse.fr",{"name":31,"role":27,"phone":19,"phoneExt":19,"email":32},"Gaelle SORIANO","soriano.g@chu-toulouse.fr",[34,52,66,79],{"facility":35,"status":36,"city":37,"state":19,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University hospital of Bordeaux","NOT_YET_RECRUITING","Bordeaux","33000","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-0.58046,44.84124,{"lat":45,"lon":44},[48,50],{"name":49,"role":27,"phone":19,"phoneExt":19,"email":19},"Emmanuelle CUGY, MD",{"name":51,"role":24,"phone":19,"phoneExt":19,"email":19},"Emmanuelle CUGY",{"facility":53,"status":36,"city":54,"state":19,"zip":55,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"University hospital of Rouen","Rouen","76038",{"type":42,"coordinates":57},[58,59],1.09932,49.44313,{"lat":59,"lon":58},[62,64],{"name":63,"role":27,"phone":19,"phoneExt":19,"email":19},"Eric VERIN, MD",{"name":65,"role":24,"phone":19,"phoneExt":19,"email":19},"Eric VERIN",{"facility":23,"status":67,"city":68,"state":19,"zip":69,"country":39,"countryCode":40,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"RECRUITING","Toulouse","31059",{"type":42,"coordinates":71},[72,73],1.44367,43.60426,{"lat":73,"lon":72},[76,77],{"name":22,"role":27,"phone":19,"phoneExt":19,"email":29},{"name":78,"role":24,"phone":19,"phoneExt":19,"email":19},"MD WOISARD, MD",{"facility":80,"status":67,"city":81,"state":19,"zip":82,"country":39,"countryCode":40,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"University hospital of Tours","Tours","37000",{"type":42,"coordinates":84},[85,86],0.70398,47.39484,{"lat":86,"lon":85},[89,91],{"name":90,"role":27,"phone":19,"phoneExt":19,"email":19},"Sylvain MORINIERE",{"name":90,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":93,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[95,97,100,102],{"name":96,"class":6},"National Research Agency, France",{"name":98,"class":99},"Institut de Recherche en Informatique de Toulouse (IRIT)","UNKNOWN",{"name":101,"class":99},"Laboratoire parole et langage",{"name":103,"class":104},"Swallis Medical","INDUSTRY","100517220","modelling-of-pharyngeal-laryngeal-effectiveness-100517220",false,"NCT06014710","Modelling of Pharyngeal Laryngeal Effectiveness","Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders","Eph-L","Inclusion criteria for patients with swallowing disorders :\n\n* Indication to perform a swallowing test (suspected or proven swallowing disorder or presence of a complication)\n* Able to follow up by phone for 6 months or have a caregiver who can answer for them\n* Affiliated subject or beneficiary of the social security system\n* Consent to participate obtained in writing and signed by the subject or, if applicable, the next of kin\u002Fsupport person\n\nInclusion criteria for healthy volunteers :\n\n* No swallowing disorder or discomfort (DHI score\\\u003C8)\n* Affiliated subject or beneficiary of the social security system\n* Signed Consent to Participate\n\nNon-inclusion criteria for patients with swallowing disorders :\n\n* Skin lesion(s) at the neck\n* Tracheotomy or tracheostomy (laryngectomy)\n* Nasogastric probe\n* Iodine allergy\n* Asthma\n* Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used\n* Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks\n* Legal protection (guardianship, curators, safeguarding of justice)\n* Pregnant and lactating women\n\nNon-inclusion criteria for healthy volunteers :\n\n* Medical history may result in chronic (history of oral-rhino-laryngeal cancer or neurological disease) or temporary (upper respiratory tract infections) swallowing impairment\n* Presence of swallowing disorder or discomfort (Deglutition Handicap Index score superior or equal to 8)\n* Skin lesion(s) at the neck\n* Tracheotomy or tracheostomy (laryngectomy)\n* Nasogastric probe\n* Iodine allergy\n* Asthma\n* Refusal or any pathology incompatible with passing one of the two reference exams or the sensors used\n* Any serious pathology (severe health or behavioral disorders) where, according to the investigator, this could expose participants to additional risks\n* Legal protection (guardianship, curators, safeguarding of justice)\n* Pregnant and lactating women",true,"ALL","18 Years",{"count":117,"type":118},520,"ESTIMATED","INTERVENTIONAL",[121],"NA","The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal cannula and oximeter) in order to identify indicators of functional efficiency of swallowing, protection of the lower airways and phonation.\n\n440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study in an interventional research study involving the prospective, multicentric and longitudinal.\n\nPharyngolaryngeal effectiveness will be measured from 6 indicators identified by examinations or reference tests grouped into 3 functions:\n\n* swallowing: pharyngeal transport capacity (Yale Residue) and Penetration Aspiration Scale (PAS) rated by videofluoroscopy of swallowing (VFS) or flexible endoscopic evaluation of swallowing (FEES);\n* airway protection: cough trigger (citric acid test) and cough power (peak expiratory flow);\n* phonation: vocal efficiency (maximum phonation time) and velar efficiency (nasal scores).\n\nThe signals obtained from the 5 sensors will be annotated. Stochastic modelling based on hidden Markov models will be used initially and followed by the implementation of deep neural networks to model indicators. For the complication's prediction algorithm, deep neural networks will also be used to evaluate signal-based methods.\n\nThe expected benefits are to obtain automated recognition of pharyngeal-laryngeal effectiveness to diagnose swallowing disorders using objective and quantifiable indicators, non-invasive devices, to assess the severity of these disorders and to identify the risk of complications.",[124],"Swallowing Disorders","2025-06-10",{"date":127,"type":128},"2025-06-13","ACTUAL",{"date":130,"type":128},"2023-04-14",{"date":132,"type":118},"2026-12",{"name":5,"class":6},4]