[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509750":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":32,"locations":42,"responsibleParty":65,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients",null,"Children aged 11 months to 21 months on the day of inclusion in the study, with profound congenital deafness and having benefited from unilateral or bilateral cochlear implantation before 18 months of life inclusive, followed at Necker-Enfants Malades hospital and who receive a speech therapy.",[13,14],"Other: LENA tool: Language ENvironment Analysis","Behavioral: Return of the analysis of the data of LENA",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"LENA tool: Language ENvironment Analysis","Recording of the language environment of the child at home, in daily environment, with the LENA.\n\nThe parameters recorded relate to four domains: \"adult words\", \"conversation turns\", \"child vocalizations\" and \"exposure to electronic media\".\n\nThe LENA box is worn for 10-16 hours, with a minimum of 10 consecutive hours. the families make 2 separate recordings of 6 months at T1 and T2.",[9],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"BEHAVIORAL","Return of the analysis of the data of LENA","The analysis of the LENA data is carried out by the speech therapist using the LENA Pro Version Software v3.4, during the times T1 and T2. The return of the analysis of the data collected via the LENA will be made to the family of the patient after T1 and after T2 and personalized advice will then be given to parents with the aim of improving their child's language skills.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Clara LEGENDRE, speech therapist","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":31},"Natalie LOUNDON, MD, PhD","STUDY_DIRECTOR",[33,38],{"name":27,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","1 71 39 67 96","+33","clara.legendre@aphp.fr",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Hélène MOREL","1 71 19 63 46","helene.morel@aphp.fr",[43],{"facility":44,"status":45,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hôpital Necker-Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,58,61,63],{"name":27,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Marine PARODI, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":10,"phoneExt":10,"email":10},"Isabelle ROUILLON, MD",{"name":64,"role":60,"phone":10,"phoneExt":10,"email":10},"Sophie ACHARD, MD",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68],{"name":69,"class":6},"URC-CIC Paris Descartes Necker Cochin","100509750","analysis-of-parental-support-in-families-using-the-lena-after-early-cochlear-implantation-100509750",false,"NCT05917496","Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation","ACLEIC","Inclusion Criteria:\n\n* Have profound congenital deafness\n* Have been implanted between 8 months and 18 months\n* Have had a unilateral or bilateral cochlear implant for 3 months\n* Be between 11 months and 21 months old on the day of inclusion\n* Constant wearing of the implant\n* Benefit from speech therapy\n* Have a French-speaking parent\n* Information and non-opposition of holders of parental authority to participate in the study\n\nExclusion Criteria:\n\n* Syndromic deafness or auditory nerve aplasia\n* Micro-cochlea or partial insertion of the electrode bundle\n* CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies\u002Fdeafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and\u002For mental retardation, genital hypoplasia, ear abnormalities\u002Fdeafness)\n* Deafness with significant central involvement (cytomegalovirus, meningitis)\n* Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)\n* Non-daily wearing of the cochlear implant\n* Proven uncorrected visual disturbances interfering with the performance of language level assessment tests","ALL","11 Months","21 Months",{"count":81,"type":82},30,"ESTIMATED","OBSERVATIONAL","The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and\u002For video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.\n\nThe purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.",[86,87],"Profound Congenital Deafness","Cochlear Implantation",[89,90,91,92,93,94],"Profound congenital deafness","Early cochlear implantation","Language environment","Child's language development","Speech therapy assessment","Language ENvironment Analysis (LENA) tool","2025-09-05",{"date":97,"type":98},"2025-09-12","ACTUAL",{"date":100,"type":98},"2024-09-13",{"date":102,"type":82},"2026-07",{"name":5,"class":6},1]