[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627747":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":46,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ipsilateral cochlear implantation to vestibular hypofunction","EXPERIMENTAL","Cochlear implantation on same side as ear with unilateral vestibular hypofunction",[13],"Procedure: Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction",{"label":15,"type":16,"description":17,"interventionNames":18},"Contralateral cochlear implantation to vestibular hypofunction","ACTIVE_COMPARATOR","Cochlear implantation on opposite side as ear with unilateral vestibular hypofunction",[19],"Procedure: Contralateral cochlear implantation in patients with unilateral vestibular hypofunction",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction","This clinical trial is designed to elucidate the effects of cochlear implantation on the same or opposite side of the ear that demonstrates vestibular weakness in balance testing. This intervention will be used to perform cochlear implantation on the same side.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Contralateral cochlear implantation in patients with unilateral vestibular hypofunction","This clinical trial is designed to elucidate the effects of cochlear implantation on the same or opposite side of the ear that demonstrates vestibular weakness in balance testing. This intervention will be used to perform cochlear implantation on the opposite side.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Benjamin Lovin, MD","CONTACT","434-924-5700","\"Lovin, Benjamin *HS\" \u003CYZA3EP@uvahealth.org>",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Elena Squire","EM8ZK@uvahealth.org",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Benjamin D. Lovin","Assistant Professor, Otology & Neurotology, Department of Otolaryngology","100627747","optimizing-cochlear-implant-laterality-in-patients-with-unilateral-vestibular-weakness-100627747",false,"NCT07452653","Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness","Inclusion Criteria:\n\n* Patients over the age of 50 years\n* Bilateral and symmetric moderate to profound sensorineural hearing loss (SNHL). Symmetric SNHL will be defined objectively as no more than 20dB difference at any 2 consecutive frequencies or no more than 15dB difference at any 3 consecutive frequencies on standard audiometry and as no significant difference between the ears to the patient.\n* Unilateral vestibular weakness. Unilateral vestibular weakness will be defined by caloric testing of a greater than 22% difference between ears using bithermal water irrigation.\n* Candidates for cochlear implantation by meeting traditional cochlear implant audiometric criteria.\n* Willingness and ability to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n* Patients with prior unilateral cochlear implantation\n* Asymmetric SNHL\n* Absence of unilateral vestibular weakness\n* Contraindication for caloric testing (including epilepsy, dysconjugate eye movements, and history of ear or eye surgery less than 2 months prior)\n* Alternative reasons for selecting cochlear implant laterality, including external. middle, or inner ear disease, anatomical abnormalities, or retrocochlear pathology\n* Pregnant women\n* Fetuses, neonates, children\n* Prisoners\n* Cognitively impaired adults","ALL","50 Years","99 Years",{"count":54,"type":55},10,"ESTIMATED","INTERVENTIONAL",[58],"NA","In patients with symmetric hearing loss who meet traditional cochlear implant candidacy criteria yet demonstrate pre-operative unilateral vestibular weakness, the choice of which ear to implant may impact their post-operative vestibular course. The investigators aim to implement both objective videonystagmography metrics as well as subjective patient-reported outcome measures to assess whether selecting laterality for cochlear implantation as it relates to unilateral vestibular loss has a measurable impact on patients' post-operative vestibular function. In pursuing cochlear implantation on the ear that demonstrates worse vestibular function, the investigators hypothesize improved vestibular function in comparison to operating on the unaffected side. The randomized control pilot study plans to allocate 10 subjects to a treatment group that involves cochlear implantation on the ipsilateral side of vestibular hypofunction and a control group that will undergo implantation on the contralateral side. The investigators plan to compare scores derived from the Dizziness Handicap Inventory completed at pre-operative evaluation and at two subsequent post-operative visits between control and treatment groups as primary outcome. The investigators also plan to determine if there is a significant difference in measures derived from caloric vestibular testing pre- and post-operatively as well as between control and treatment groups.",[61,62],"Sensorineural Hearing Loss","Vestibular Hypofunction",[64,65,66,67],"cochlear implantation","sensorineural hearing loss","vestibular hypofunction","vestibular weakness","NOT_YET_RECRUITING","2026-03-06",{"date":71,"type":72},"2026-03-10","ACTUAL",{"date":74,"type":55},"2026-04",{"date":76,"type":55},"2027-12",{"name":5,"class":6}]