Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

NCT ID: NCT04066270

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Hearing Loss, Sensorineural Bilateral Vestibular Deficiency DFNA9 Radiology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

video nystagmography

Intervention Type DIAGNOSTIC_TEST

routine test battery applied to all cochlear implant candidates

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

video nystagmography

Intervention Type DIAGNOSTIC_TEST

routine test battery applied to all cochlear implant candidates

Interventions

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video nystagmography

routine test battery applied to all cochlear implant candidates

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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video head impulse test c & o VEMP (vestibular-evoked myogenic potentials) CT scan temporal bone MR temporal bone tonal liminar audiometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sebastien Janssens de Varebeke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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sebastien P JanssensdeVarebeke, MD

Role: CONTACT

011337420

Facility Contacts

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sebastien P Janssens, MD

Role: primary

011 337420

Other Identifiers

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JessaH-3

Identifier Type: -

Identifier Source: org_study_id

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