NCT04066270

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

4.3 years

First QC Date

August 21, 2019

Last Update Submit

March 29, 2022

Conditions

Hearing Loss, SensorineuralBilateral Vestibular DeficiencyDFNA9Radiology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • audiometry

    at time of recruitment

  • vestibular function 1

    at time of recruitment

  • vestibular function 2

    at time of recruitment

  • vestibular function 3

    at time of recruitment

Study Arms (2)

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

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

Interventions

video nystagmographyDIAGNOSTIC_TEST

routine test battery applied to all cochlear implant candidates

Also known as: video head impulse test, c & o VEMP (vestibular-evoked myogenic potentials), CT scan temporal bone, MR temporal bone, tonal liminar audiometry
control groupstudy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Hearing Loss, SensorineuralBilateral Vestibulopathy

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials, MotorEvoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological Phenomena

Central Study Contacts

sebastien P JanssensdeVarebeke, MD

CONTACT

011337420drsjanssens@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

September 1, 2019

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)