Vestibular Function in Cochlear Implants

February 7, 2024 updated by: Marketa Bonaventurova, Charles University, Czech Republic

Genetic Background of Hearing Loss and Vestibular Function Evaluation Following Cochlear Implantation

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 15006
        • Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

57 adult CI recipients The indication for surgery was hearing impairment. Round window approach was used preferably for insertion of the electrode array. Anamestic data as a history of hearing impairment, family history and the use of hearing aids were collected from all the patients.

They underwent routine vestibular testing before and after the intervention.

Description

Inclusion Criteria:

  • profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion Criteria:

  • profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear implant recipients
57 consecutive cochlear implant recipients
Procedure: cochlear implantation
surgery for bilateral hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vestibular function
Time Frame: from 2 days before the intervention to 3 weeks after the intervention
semicircular canal function measured by vHIT
from 2 days before the intervention to 3 weeks after the intervention
vestibular function
Time Frame: from 2 days before the intervention to 3 weeks after the intervention
otolith function measured by VEMP
from 2 days before the intervention to 3 weeks after the intervention
postural function
Time Frame: from 2 days before the intervention to 3 weeks after the intervention
postural function and stability measured by stabilometry
from 2 days before the intervention to 3 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Study Chair: Zuzana Balatkova, Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CharlesUCZ

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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