[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504370":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":127,"collaborators":24,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":24,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":24,"enrollmentInfo":139,"targetDuration":24,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"The Bionics Institute of Australia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Provision of standard audiological + fNIRS test results","EXPERIMENTAL","The treatment arm involves the provision of additional fNIRS sound detection and speech discrimination test results to the audiologists, in addition to standard audiology information. Standard information includes:\n\n1. At diagnosis: unaided Auditory Brainstem Response results;\n2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;\n3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);\n4. After initial cochlear implant programming: behavioural observations.",[13],"Other: Provision of standard audiological + fNIRS test results",{"label":15,"type":16,"description":17,"interventionNames":18},"Provision of standard audiological test results only","ACTIVE_COMPARATOR","The standard audiology information available to the audiologists includes:\n\n1. At diagnosis: unaided Auditory Brainstem Response results;\n2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;\n3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);\n4. After initial cochlear implant programming: behavioural observations.",[19],"Other: Provision of standard audiological test results only",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Infants with hearing loss will be tested using functional near-infrared spectroscopy (fNIRS) and a patented analysis algorithm to measure sound detection and discrimination. Their standard audiological test results will also be collected from their audiology service provider\u002Fs. Both sets of test results will be given to the participating audiologists in the experimental arm.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.",[15],[29],{"name":30,"affiliation":5,"role":31},"Professor Colette McKay","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+61 3 9667 7541","cmckay@bionicsinstitute.org",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Dr Julia Wunderlich","+61 3 9667 7500","hearingstudy@bionicsinstitute.org",[42,64,85,99,113],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Royal Victorian Eye and Ear Hospital","NOT_YET_RECRUITING","East Melbourne","Victoria","3002","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],144.9879,-37.81667,{"lat":54,"lon":53},[57,61],{"name":58,"role":34,"phone":59,"phoneExt":24,"email":60},"Jaime Leigh","+61399298624","jaime.leigh@eyeandear.org.au",{"name":62,"role":34,"phone":59,"phoneExt":24,"email":63},"Rebecca Farrell","rebecca.farrell@eyeandear.org.au",{"facility":65,"status":66,"city":67,"state":46,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Bionics Institute","RECRUITING","Fitzroy","3065",{"type":51,"coordinates":70},[71,72],144.97833,-37.79839,{"lat":72,"lon":71},[75,77,78,79,81,83],{"name":76,"role":34,"phone":35,"phoneExt":24,"email":36},"Prof Colette McKay",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},{"name":76,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":38,"role":80,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":82,"role":80,"phone":24,"phoneExt":24,"email":24},"Dr Darren Mao",{"name":84,"role":80,"phone":24,"phoneExt":24,"email":24},"Dr Gautam Balasubramanian",{"facility":86,"status":44,"city":87,"state":46,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Barwon Health","Geelong","3220",{"type":51,"coordinates":90},[91,92],144.36069,-38.14711,{"lat":92,"lon":91},[95],{"name":96,"role":34,"phone":97,"phoneExt":24,"email":98},"Rachael Hyder","+61342150873","rachael.hyder@barwonhealth.org.au",{"facility":100,"status":44,"city":101,"state":46,"zip":102,"country":48,"countryCode":49,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Hearing Australia","Moonee Ponds","3039",{"type":51,"coordinates":104},[105,106],144.91667,-37.76667,{"lat":106,"lon":105},[109],{"name":110,"role":34,"phone":111,"phoneExt":24,"email":112},"Lauren Burns","+61383259000","lauren.burns@hearing.com.au",{"facility":114,"status":66,"city":115,"state":46,"zip":116,"country":48,"countryCode":49,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"The Royal Children's Hospital","Parkville","3052",{"type":51,"coordinates":118},[119,120],144.95,-37.78333,{"lat":120,"lon":119},[123],{"name":124,"role":34,"phone":125,"phoneExt":24,"email":126},"Jane Sheehan","+61393455675","jane.sheehan3@rch.org.au",{"type":31,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Colette McKay","Leader, Translational Hearing Research and Principal Scientist","100504370","improving-early-intervention-in-hearing-impaired-children-using-functional-near-infrared-spectroscopy-fnirs-100504370",false,"NCT05847426","Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)","The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study\n\nAudiologist Inclusion Criteria:\n\n* Is a qualified audiologist who meets the criteria for membership of Audiology Australia.\n* Has at least 1 year of experience in paediatric diagnostic, hearing aid or cochlear implant audiology service provision in Australia.\n* Provides a signed and dated informed consent form.\n\nAudiologist Exclusion criteria (only for a specific infant test result):\n\n* Is the managing audiologist for the infant who's results are being provided.\n\nInfants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test.\n\nInfant Inclusion criteria:\n\n* Between the ages of 1 and 24 months at the time of fNIRS testing.\n* Has permanent hearing loss in one or both ears as determined by audiological diagnostic testing.\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nInfant Exclusion Criteria:\n\n* There are no exclusion criteria other than not meeting the inclusion criteria.",true,"ALL","24 Years",{"count":140,"type":141},40,"ESTIMATED","INTERVENTIONAL",[144],"NA","The goal of this clinical trial is to find out whether hearing test results using functional near-infrared spectroscopy (fNIRS) will help to fast-track early intervention for infants born with a hearing loss. fNIRS is a method of imaging brain activity using light. The main questions are:\n\n1. Can audiologists make more confident decisions about the optimal interventions at different critical points in the hearing care pathway when they are given additional fNIRS information compared to when they have standard audiology test results alone?\n2. Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?",[147],"Hearing Impairment",[149,150,151],"Infants","Early intervention","functional near-infrared spectroscopy","2025-08-14",{"date":154,"type":155},"2025-08-19","ACTUAL",{"date":157,"type":155},"2023-05-02",{"date":159,"type":141},"2028-04-28",{"name":5,"class":6},5]