[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482168":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":62,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Place-based map","EXPERIMENTAL","CIs will be mapped according to each participant's unique place-based map using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map than the one they were assigned for 1 additional month. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.",[13],"Other: Place-based cochlear implant mapping",{"label":15,"type":16,"description":17,"interventionNames":18},"Default map","ACTIVE_COMPARATOR","CIs will be mapped according to the clinical default program using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map for 1 additional month from the one they were randomly assigned. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.",[19],"Other: Default cochlear implant mapping",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Place-based cochlear implant mapping","Pre-operative, 3D CT scans of the temporal bone will be uploaded into a deep learning-based tool which automatically resamples, crops, segments, analyzes, and measures the patient's specific cochlear anatomy. These measurements will be input into an individualized pitch mapping function to determine a patient-specific tonotopic distribution of frequencies (place-based map). At device activation (approximately 1 month post-surgery) CIs will be programmed according to the place-based map.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Default cochlear implant mapping","At device activation (approximately 1 month post-surgery) CIs will be programmed according to the clinical default program.",[15],[31],{"name":32,"affiliation":33,"role":34},"Sumit K Agrawal, MD","Western University","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","519-663-3568","sumit.agrawal@lhsc.on.ca",[41],{"facility":33,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","London","Ontario","N6A 3K7","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-81.23304,42.98339,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":58,"email":39},"Sumit Agrawal","5196858500 x","33568",{"name":60,"role":37,"phone":25,"phoneExt":25,"email":61},"Lauren Siegel","lauren.siegel@schulich.uwo.ca",{"type":34,"investigatorFullName":56,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[65,67,69],{"name":66,"class":6},"Academic Medical Organization of Southwestern Ontario",{"name":68,"class":6},"University of North Carolina",{"name":70,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","100482168","place-based-cochlear-implant-mapping-100482168",false,"NCT05558514","Place-based Cochlear Implant Mapping","Performance Comparisons With Default Versus Place-based Maps","Inclusion Criteria:\n\n* Adults (18 years of age or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD)\n* Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) to undergo unilateral cochlear implantation\n* Identify as a native English speaker (recorded speech recognition\u002Fperception materials are presented in English)\n* Deny any cognitive issues\n* Willing and able to participate in study procedures (e.g., unaided testing, speech recognition testing, spatial hearing testing)\n* Willing and able to return for follow-up visits (same intervals as recommended clinically for routine follow-up)\n\nExclusion Criteria:\n\n* Fail the Mini Mental State Examination based on their age and education level","ALL","18 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","The current standard of care approach for programming cochlear implants uses a generalized pitch-map for all patients. This approach fails to account for individualized inner ear anatomy. As a result, many cochlear implant recipients experience place-pitch mismatch. We have recently developed an automated mathematical tool to produce patient-specific, customized cochlear implant pitch-maps (Helpard et al., 2021). In this study, cochlear implant recipients will be randomized to receive either the clinical default pitch-map (the control group) or a place-based pitch-map (the intervention group).\n\nAssessments will be conducted at multiple time-intervals to account for patient acclimation and plasticity to both the generalized and individualized pitch-maps. Audiological assessments will be tuned to identify patients' ability to discern pitch scaling and variation in sounds, as well as to understand complexities in speech such as mood and tone. Audiological testing will be conducted in collaboration with the National Centre for Audiology (London, ON) to ensure that the most accurate and relevant metrics are applied.",[88,89],"Hearing Loss, Sensorineural","Cochlear Implants",[91,92,93,94,95],"cochlear implant","pitch map","hearing loss","cochlear implant programming","place-pitch mismatch","2025-03-24",{"date":98,"type":99},"2025-03-28","ACTUAL",{"date":101,"type":99},"2023-06-07",{"date":103,"type":82},"2026-05",{"name":5,"class":6},1]