Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

• Conditions: Radiology; Hearing Loss, Sensorineural; DFNA9; Bilateral Vestibular Deficiency
• Interventions: Diagnostic Test: video nystagmography

• Registration Number: NCT04066270
• Lead Sponsor: Jessa Hospital

Brief Summary

In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT \& MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2019-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• must be eligible for cochlear implantation
• must be 18 years of age or older

Exclusion Criteria

• <18 years of age
• not eligible to undergo vestibular tests, especially videonystagmography
• contra-indication for MR or CT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	video nystagmography	Symptomatic DFNA9 patients carrying the p.P51S mutation in COCH, presenting the radiologic semicircular canal lesion(s) on CT and/or MR. clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone
study group	video nystagmography	candidates for cochlear implantation 18 years or older, who are eligible for implantation for the indication of bilateral severe hearing loss or single sided deafness. clinical audiometric and vestibular investigations, CT and MR imaging of petrous bone

Primary Outcome Measures

Name	Time	Method
CT/MR of SCC	at time of recruitment	lesions to one or more semicircular canals on CT and/or MR of temporal bone
p.P51S	at time of recruitment	carriers hip of p.P51S mutation in COCH

Secondary Outcome Measures

Name	Time	Method
vestibular function 1	at time of recruitment	video nystagmography
vestibular function 2	at time of recruitment	video head impulse test
audiometry	at time of recruitment	tonale liminar audiometry thresholds
vestibular function 3	at time of recruitment	vestibular evoked myogenic potentials

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium