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