Cochlear Implant and Vestibular Function.

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Brief Title

Cochlear Implant and Vestibular Function.

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Vestibular function

Secondary Outcome

 Subjective dizziness

Condition

Sensorineural Hearing Loss

Intervention

Round window approach

Study Arms / Comparison Groups

 Cochleostomy
Description:  In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

August 2015

Completion Date

December 2017

Primary Completion Date

December 2017

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
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Leise Korsager, BSc, +45 223 667 18, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02584361

Organization ID

47190


Responsible Party

Principal Investigator

Study Sponsor

Odense University Hospital


Study Sponsor

Leise Korsager, BSc, Principal Investigator, Odense University Hospital


Verification Date

October 2015