Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, Sensorineural; DFNA9; Radiology; Bilateral Vestibular Deficiency
• Intervention / Treatment: Diagnostic test: video nystagmography

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: sebastien P JanssensdeVarebeke, MD; Phone Number: 011337420; Email: drsjanssens@gmail.com

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: sebastien P Janssens, MD; Phone Number: 011 337420; Email: drsjanssens@gmail.com
      • Principal Investigator: sebastien PF Janssens, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

-all patients with severe hearing loss who are eligible for cochlear implantation who do not carry the p.P51S mutation in COCH and are at least 18 years of age

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; 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	Diagnostic test: video nystagmography; routine test battery applied to all cochlear implant candidates; Other Names: video head impulse test; c & o VEMP (vestibular-evoked myogenic potentials); CT scan temporal bone; MR temporal bone; tonal liminar audiometry
control group; 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	Diagnostic test: video nystagmography; routine test battery applied to all cochlear implant candidates; Other Names: video head impulse test; c & o VEMP (vestibular-evoked myogenic potentials); CT scan temporal bone; MR temporal bone; tonal liminar audiometry

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
audiometry	tonale liminar audiometry thresholds	at time of recruitment
vestibular function 1	video nystagmography	at time of recruitment
vestibular function 2	video head impulse test	at time of recruitment
vestibular function 3	vestibular evoked myogenic potentials	at time of recruitment

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural; Bilateral Vestibulopathy
• Other Study ID Numbers: JessaH-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No