[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483210":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":146,"collaborators":148,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":10,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":10,"maxAge":158,"enrollmentInfo":159,"targetDuration":10,"studyType":162,"phases":10,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Akouos, Inc.","INDUSTRY",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Retrospective",null,[12],"Other: Natural History Study",{"label":14,"type":10,"description":10,"interventionNames":15},"Prospective",[12],[17],{"type":18,"name":19,"description":19,"armGroupLabels":20,"otherNames":10},"OTHER","Natural History Study",[14,9],[22],{"name":23,"affiliation":24,"role":25},"Peter Marks, MD","Eli Lilly and Company","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Akouos Clinical Trials","CONTACT","+1 857 410 1816","AkouosClinicalTrials@Lilly.com",[33,47,57,67,77,90,101,113,124,135],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"University of Iowa","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-91.53017,41.66113,{"lat":45,"lon":44},{"facility":48,"status":35,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":10},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":42,"coordinates":53},[54,55],-84.51439,39.12711,{"lat":55,"lon":54},{"facility":58,"status":35,"city":59,"state":60,"zip":61,"country":39,"countryCode":40,"cosmosGeoPoint":62,"geoPoint":66,"contacts":10},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":42,"coordinates":63},[64,65],-75.16362,39.95238,{"lat":65,"lon":64},{"facility":68,"status":35,"city":69,"state":70,"zip":71,"country":39,"countryCode":40,"cosmosGeoPoint":72,"geoPoint":76,"contacts":10},"Vanderbilt University Medical Center","Nashville","Tennessee","37232-8605",{"type":42,"coordinates":73},[74,75],-86.78444,36.16589,{"lat":75,"lon":74},{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":10},"Murdoch Children's Research Institute","WITHDRAWN","Parkville","Victoria","VIC 3052","Australia","AU",{"type":42,"coordinates":86},[87,88],144.95,-37.78333,{"lat":88,"lon":87},{"facility":91,"status":35,"city":92,"state":10,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"University Hospital in Tübingen","Tübingen","72076","Germany","DE",{"type":42,"coordinates":97},[98,99],9.05222,48.52266,{"lat":99,"lon":98},{"facility":102,"status":35,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":10},"Sant Joan de Déu Barcelona Hospital","Esplugues de Llobregat","Barcelona","08950","Spain","ES",{"type":42,"coordinates":109},[110,111],2.08809,41.37732,{"lat":111,"lon":110},{"facility":114,"status":35,"city":115,"state":10,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":10},"National Taiwan University Hospital","Taipei","100","Taiwan","TW",{"type":42,"coordinates":120},[121,122],121.52639,25.05306,{"lat":122,"lon":121},{"facility":125,"status":35,"city":126,"state":127,"zip":128,"country":129,"countryCode":10,"cosmosGeoPoint":130,"geoPoint":134,"contacts":10},"Ankara University","Ankara","Turkey","06230","Turkey (Türkiye)",{"type":42,"coordinates":131},[132,133],32.85427,39.91987,{"lat":133,"lon":132},{"facility":136,"status":35,"city":137,"state":138,"zip":139,"country":138,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":10},"University College London","London","United Kingdom","NW1 2PG","UK",{"type":42,"coordinates":142},[143,144],-0.12574,51.50853,{"lat":144,"lon":143},{"type":147,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[149],{"name":24,"class":6},"100483210","otoferlin-gene-mediated-hearing-loss-natural-history-study-100483210",false,"NCT05572073","Otoferlin Gene-mediated Hearing Loss Natural History Study","A Natural History Study in Individuals With Otoferlin Gene-mediated Hearing Loss","Inclusion Criteria:\n\n1. Clinical presentation of bilateral sensorineural hearing loss (SNHL), including auditory neuropathy (AN) \u002F auditory neuropathy spectrum disorder (ANSD) phenotype or medical history of AN \u002F ANSD phenotype earlier in life\n2. Mutation(s) in the otoferlin gene\n3. Able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process\n\n   Additional Criteria for Inclusion in the Prospective Phase:\n4. Presence of OAE \u002F CM and absent \u002F abnormal ABRs in at least one ear (that does not have a cochlear implant) within 12 months prior to or at the Month 0 visit\n\nExclusion Criteria:\n\n1. Unwillingness or inability of the potential participant and\u002For legally authorized representative to comply with all protocol requirements\n2. Presence of cochlear nerve deficiency and\u002For cochlear nerve dysplasia\n\n   Additional Criteria for Exclusion from the Prospective Phase:\n3. Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months\n4. Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months\n5. Any condition that would not allow the potential participant to complete follow-up assessments during the course of the study and\u002For, in the opinion of the Investigator, makes the potential participant unsuitable for the study\n\nNote: Potential participants will not be excluded based on their sex, gender, race, or ethnicity","ALL","44 Years",{"count":160,"type":161},150,"ESTIMATED","OBSERVATIONAL","This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.",[165],"Sensorineural Hearing Loss, Bilateral",[167],"Otoferlin Gene, sensorineural hearing loss (SNHL), auditory neuropathy, auditory neuropathy spectrum disorder","2026-03-03",{"date":170,"type":171},"2026-03-04","ACTUAL",{"date":173,"type":171},"2022-07-14",{"date":175,"type":161},"2029-02",{"name":5,"class":6},10]