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Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066270
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastien Janssens de Varebeke, 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.

Condition or disease Intervention/treatment
Hearing Loss, Sensorineural Bilateral Vestibular Deficiency DFNA9 Radiology Diagnostic Test: video nystagmography

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. CT/MR of SCC [ Time Frame: at time of recruitment ]
    lesions to one or more semicircular canals on CT and/or MR of temporal bone

  2. p.P51S [ Time Frame: at time of recruitment ]
    carriers hip of p.P51S mutation in COCH


Secondary Outcome Measures :
  1. audiometry [ Time Frame: at time of recruitment ]
    tonale liminar audiometry thresholds

  2. vestibular function 1 [ Time Frame: at time of recruitment ]
    video nystagmography

  3. vestibular function 2 [ Time Frame: at time of recruitment ]
    video head impulse test

  4. vestibular function 3 [ Time Frame: at time of recruitment ]
    vestibular evoked myogenic potentials



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066270


Contacts
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Contact: sebastien P JanssensdeVarebeke, MD 011337420 drsjanssens@gmail.com

Locations
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Belgium
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: sebastien P Janssens, MD    011 337420    drsjanssens@gmail.com   
Principal Investigator: sebastien PF Janssens, MD         
Sponsors and Collaborators
Jessa Hospital
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Responsible Party: Sebastien Janssens de Varebeke, Principal Investigator, Jessa Hospital
ClinicalTrials.gov Identifier: NCT04066270    
Other Study ID Numbers: JessaH-3
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Bilateral Vestibulopathy
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases