Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

Hearing Loss, Sensorineural Clinical Trial

Official title:

Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066270
• Other study ID #: JessaH-3
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2022
• Source: Jessa Hospital
• Contact: sebastien P JanssensdeVarebeke, MD
• Phone: 011337420
• Email: drsjanssens[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Vestibular Deficiency
• Bilateral Vestibulopathy
• DFNA9
• Hearing Loss
• Hearing Loss, Sensorineural
• Radiology

Intervention

Diagnostic Test:
• video nystagmography
routine test battery applied to all cochlear implant candidates

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT/MR of SCC	lesions to one or more semicircular canals on CT and/or MR of temporal bone	at time of recruitment
Primary	p.P51S	carriers hip of p.P51S mutation in COCH	at time of recruitment
Secondary	audiometry	tonale liminar audiometry thresholds	at time of recruitment
Secondary	vestibular function 1	video nystagmography	at time of recruitment
Secondary	vestibular function 2	video head impulse test	at time of recruitment
Secondary	vestibular function 3	vestibular evoked myogenic potentials	at time of recruitment