[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546901":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":52,"centralContacts":57,"locations":68,"responsibleParty":89,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":29,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":71,"whyStopped":29,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Bilaterally implanted patients","EXPERIMENTAL","patient with two cochlear implant in each ear",[13,14,15,16,17,18],"Device: Cochlear implant processor Sky CITM M90 (CI-5295)","Device: Hearing Aid, including sound processor Phonak: Sky Link M90","Diagnostic Test: French simplified matrix test (FraSimat)","Behavioral: Audiologist Fitting Questionnaire","Behavioral: Patient Satisfaction Questionnaire","Behavioral: AutoSens Feedback Discussion Form",{"label":20,"type":10,"description":21,"interventionNames":22},"Bimodal patients","patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear",[14,15,16,17,18],[24,30,34,39,44,48],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Cochlear implant processor Sky CITM M90 (CI-5295)","The Sky CI available to included patients (no procedures added) offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion:\n\n1. Omnidirectional mode : no sound treatment\n2. AS Target : Autosense is active and no modifications are made by clinician\n3. AS Clinique : Autosense is active and modified by the clinician",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Hearing Aid, including sound processor Phonak: Sky Link M90","The device is fitting and programmed for home especially for the purpose research at inclusion. The Clinical map parameters will be verified according to clinical routine.\n\nThe Sky Link offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion:\n\n1. Omnidirectional mode : no sound treatment\n2. AS Target : Autosense is active and no modifications are made by clinician\n3. AS Clinique : Autosense is active and modified by the clinician",[9,20],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"DIAGNOSTIC_TEST","French simplified matrix test (FraSimat)","The FraSimat speech in noise test will be tested, 6 months before inclusion in the three different fitting configurations: omni, AS clinic, AS Target. The speech will be presented from the front, noise from 180°. Noise will be presented at a fixed level of 65 dB SPL while the speech signal will be adapted to find the 50% speech reception threshold (SRT).",[9,20],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":29},"BEHAVIORAL","Audiologist Fitting Questionnaire","After the fitting of Hearing Aid at inclusion, the audiologist will complete a questionnaire describing the fitting and justifying fitting decisions and will collect the demographic information",[9,20],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"Patient Satisfaction Questionnaire","The patient will be giving a Patient satisfaction Questionnaire, with questions regarding device and accessory use. The audiologist will go over the instructions for filling out the questionnaire at inclusion. Patients will be asked to complete the questionnaire and return it at the next visit, 6 months after inclusion.",[9,20],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":29},"AutoSens Feedback Discussion Form","6 months after inclusion and fitting, the audiologist discusses the use of AS clinic with the subject and completes the AS questionnaire (questionnaire on the experience of using the processor in different listening situations).",[9,20],[53],{"name":54,"affiliation":55,"role":56},"Nathalie LOUNDON, MD,PhD","APHP","STUDY_DIRECTOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Nathalie LOUNDON, MD, PhD","CONTACT","01 71 39 67 82","+33","natalie.loundon@aphp.fr",{"name":65,"role":60,"phone":66,"phoneExt":62,"email":67},"Gael PLASTOW","0144381711","gael.plastow@aphp.fr",[69],{"facility":70,"status":71,"city":72,"state":29,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Audiophonology Unit of the Ear, Nose and Throat (ENT) Department (\"Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale\") at the Necker-Enfants Malades hospital (AP-HP).","RECRUITING","Paris","75015","France","FR",{"type":77,"coordinates":78},"Point",[79,80],2.3488,48.85341,{"lat":80,"lon":79},[83,87],{"name":84,"role":60,"phone":85,"phoneExt":62,"email":86},"Melissa MACSKILL","01 87 89 29 14","melissa.macaskill-ext@aphp.fr",{"name":54,"role":88,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"type":90,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[92,95],{"name":93,"class":94},"Advanced Bionics AG","INDUSTRY",{"name":96,"class":6},"URC-CIC Paris Descartes Necker Cochin","100546901","investigation-of-sky-automatic-technologies-in-pediatrics-100546901",false,"NCT06400992","Investigation of Sky Automatic Technologies in Pediatrics","SKY-MARVEL","Inclusion Criteria:\n\n* Be between 6 and 16 years of age at the time of inclusion\n* Use spoken French as their primary mode of communication\n* Ability to perform the Simplified French Matrix test in Noise\n* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid\n* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors\n* Obtain signed consent from legal guardian(s)\n* Be enrolled in a health insurance plan or eligible for coverage\n\nExclusion Criteria:\n\n* Severe neurological pathology identified prior to inclusion identified by MRI + \u002F- neuro-pediatric workup\n* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion\n* Family does not understand French","ALL","6 Years","16 Years",{"count":108,"type":109},20,"ESTIMATED","INTERVENTIONAL",[112],"NA","The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.",[115],"Hearing Loss",[115,117,118,119,120,121,122,123,124,125],"cochlear implant","hearing aid","hearing device","hearing system","Simplified French Matrix Test","Noise block","background noise","target cochlear implant","pediatric cochlear implant processor","2026-03-30",{"date":128,"type":129},"2026-04-03","ACTUAL",{"date":131,"type":129},"2024-12-11",{"date":133,"type":109},"2027-06",{"name":5,"class":6},1]