[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594828":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":18,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Congenital Hearing Loss Group","EXPERIMENTAL","The study will recruit patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy.",[13],"Other: Rehabilitation training",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Controls Group","NO_INTERVENTION","The study will recruit participants with normal hearing thresholds (≤20 dB) whose age and gender were matched to the patient group.Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .Healthy Controls Group were only enrolled in the Stage 1 for reliability and validity assessment, but not the Stage 2 for rehabilitation training.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Rehabilitation training","This study constructed a novel multimodal assessment system to evaluate speech perception, music perception, and spatial hearing in congenital deafness patients , and subsequently generated targeted rehabilitation training plan based on the assessment data.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Yilai Shu, M.D.& Ph.D.","CONTACT","+86 21 6437 7134","yilai_shu@fudan.edu.cn",[31],{"facility":5,"status":32,"city":33,"state":18,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Shanghai","200031","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[48],{"name":49,"class":50},"Shanghai Rehabilitation Institute for the Exceptional Children","UNKNOWN","100594828","perceptual-evaluation-and-rehabilitation-system-development-for-congenital-hearing-loss-100594828",false,"NCT07024524","Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss","Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness","Inclusion Criteria:\n\nFor Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.\n\nFor Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.\n\nMandarin Chinese as the native language. Participants and\u002For their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.\n\nCapable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.\n\nParticipants and\u002For their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.\n\nExclusion Criteria:\n\nPresence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.\n\nPresence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.\n\nIndividuals with low immunity, a history of immune deficiency or organ transplantation.\n\nIndividuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.\n\nAny other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.",true,"ALL","1 Year","35 Years",{"count":63,"type":64},210,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.",[70,71,72,73,74],"Congenital Hearing Loss","Gene Therapy","Speech Perception","Rehabilitation","Reliability and Validity",[76,77,78,79,80,81,73],"Congenital hearing loss","Gene therapy","Multimodal assessment","Auditory speech perception","Music perception","Spatial hearing","2025-07-24",{"date":84,"type":85},"2025-07-28","ACTUAL",{"date":87,"type":85},"2025-07-04",{"date":89,"type":64},"2028-05-05",{"name":5,"class":6},1]