[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623094":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":37,"responsibleParty":94,"collaborators":98,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":20,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":126,"whyStopped":20,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with normal hearing and with hearing loss","EXPERIMENTAL","Infants with clinically confirmed normal hearing and hearing loss. Participants will undergo up to 2 recording sessions of speech-evoked envelope following responses (EFRs) using the newly developed prototype device in both unaided (for normal hearing) and aided conditions (if child has been fit with hearing aids). If applicable, hearing aid settings will be recorded; their device settings will not be altered. Hearing assessment results and acoustic measures will be obtained through chart review with caregiver consent.",[13],"Device: A newly developed prototype device for speech-evoked EFR Measurement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","A newly developed prototype device for speech-evoked EFR Measurement","Speech-evoked envelope following responses (EFRs) are measured using the newly developed clinical prototype to objectively assess auditory responses. Surface electrodes are placed on the head, a non-sense speech stimulus is presented at an average level, and EFRs are recorded for 15-30 minutes while patient sleeps or is at rest.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Susan Scollie, PhD","Western University","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"David Purcell, PhD",[29,34],{"name":23,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","519-661-2111","88948","scollie@nca.uwo.ca",{"name":35,"role":30,"phone":20,"phoneExt":20,"email":36},"Krystal Beh, MClSc","kbeh@nca.uwo.ca",[38,56,77],{"facility":39,"status":20,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"National Acoustic Laborartory","Macquarie Park","Sydney","NSW 2113","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],151.12757,-33.78105,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":54,"phoneExt":20,"email":55},"Viji Easwar","+61 2 9412 7026","viji.easwar@nal.gov.au",{"facility":57,"status":20,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Dalhousie University","Halifax","Nova Scotia","B3H4R2","Canada","CA",{"type":46,"coordinates":64},[65,66],-63.57688,44.64269,{"lat":66,"lon":65},[69,73,74],{"name":70,"role":30,"phone":71,"phoneExt":20,"email":72},"Steven Aiken, PhD","902-494-7052","steve.aiken@dal.ca",{"name":70,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":75,"role":76,"phone":20,"phoneExt":20,"email":20},"Michel Comeau, MSc","SUB_INVESTIGATOR",{"facility":78,"status":20,"city":79,"state":80,"zip":81,"country":61,"countryCode":62,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"National Centre for Audiology at Western University","London","Ontario","N6G1H1",{"type":46,"coordinates":83},[84,85],-81.23304,42.98339,{"lat":85,"lon":84},[88,89,90,91,92],{"name":23,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":27,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":35,"role":76,"phone":20,"phoneExt":20,"email":20},{"name":93,"role":76,"phone":20,"phoneExt":20,"email":20},"Bavadharani Venkatesan, PhD",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Susan Scollie","Professor",[99],{"name":57,"class":6},"100623094","speech-evoked-auditory-potentials-multisite-pediatric-evaluation-100623094",false,"NCT07392164","Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation","SEFR","Inclusion Criteria:\n\n1. Infants (3 to 24 months of age) with normal hearing who have passed their audiological diagnostic evaluation\n2. Infants (3 to 24 months of age) identified with hearing loss at their audiological diagnostic evaluation, whose parents have chosen spoken language as their form of communication, and who have been prescribed and fitted with a hearing aid(s).\n\nExclusion Criteria:\n\nParticipants who have abnormal middle ear measure results or occluding ear wax will be excluded.",true,"ALL","3 Months","24 Months",{"count":112,"type":113},20,"ESTIMATED","INTERVENTIONAL",[116],"NA","The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without hearing aids? and 2) How do the measured brain responses from infants with hearing loss compare to infants with normal hearing who are the same age? Participants will have their brain responses measured using the prototype in response to average-level non-sense speech sounds across 1 to 2 sessions in a \"no-hearing aids\" condition. Participants with hearing loss who are already fit with hearing aids will additionally undergo a \"with hearing aids\" recording condition.",[119],"Hearing Impairment",[121,122,123,124,125],"Hearing","Hearing impairment","Hearing aids","Evoked potentials","Pediatrics","NOT_YET_RECRUITING","2026-01-29",{"date":129,"type":130},"2026-02-06","ACTUAL",{"date":132,"type":113},"2026-03",{"date":134,"type":113},"2026-12",{"name":96,"class":6},3]