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NCT05795530 Clinical Trial

Vestibular Function in Cochlear Implants

Vestibular Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05795530
Other study ID # CharlesUCZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date June 30, 2020

Study information
Verified date February 2024
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date June 30, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cochlear implantation
surgery for bilateral hearing loss

Locations
Country Name City State
Czechia Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School Prague

Sponsors (1)
Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary vestibular function semicircular canal function measured by vHIT from 2 days before the intervention to 3 weeks after the intervention
Primary vestibular function otolith function measured by VEMP from 2 days before the intervention to 3 weeks after the intervention
Primary postural function postural function and stability measured by stabilometry from 2 days before the intervention to 3 weeks after the intervention
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