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Clinical Trials/NCT02584361
NCT02584361
Unknown
Not Applicable

Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.

Odense University Hospital1 site in 1 country50 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensorineural Hearing Loss
Sponsor
Odense University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Vestibular function
Last Updated
10 years ago

Overview

Brief Summary

This study investigate weather one type of cochlear implant (CI) surgery (insertion of the electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI surgery to clarify their vestibular function.

Detailed Description

Cochlear implant is an advanced type of hearing advice. It consists of an outer microphone, which picks up sound and sends it through an electrode into the cochlear. With a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back. Vertigo is one of the most common side effects to cochlear implant surgery. In this study we will investigate if one type of CI surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of CI surgery (cochleostomy). In the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). Three different surgeons will do the surgeries. All technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically. Electrodes from Cochlear, MEDEL and AB is being used. We will compare the findings from the vHIT examination with the subject dizziness perceived of the patient. The patients will be examined before surgery, the day after their surgery and one month after their surgery. The same examinator will perform all the vHIT tests. The test will be performed in continuation of the patient's other visits at the Department of Audiology and Department of Otorhinolaryngology -Head and Neck Surgery.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leise Elisabeth Hviid Korsager

BSc

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • deaf or severe hard of hearing
  • normal or slightly affected vestibular function (gain \>0,50)

Exclusion Criteria

  • subjects with otosclerosis
  • subject who will have the CI surgery for preservation of the residual hearing

Outcomes

Primary Outcomes

Vestibular function

Time Frame: 1 month

Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation

Secondary Outcomes

  • Subjective dizziness(1 month)
  • Dizziness(1 month)
  • T level(1 month)
  • NRT level(1 month)
  • C level(1 month)

Study Sites (1)

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