Deafness, Hearing Loss, Sensorineural Hearing Loss
Conditions
Keywords
Hearing loss, Cochlear implant
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.
Interventions
PROCEDURERound window approach
In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA).
PROCEDURECochleostomy
In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vestibular function | 1 month | Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective dizziness | 1 month | Measured by Dizziness Handicap Inventory Score (DHI). |
| Dizziness | 1 day | Measured by a visuel analog scale (VAS) the day after cochlear implant surgery. |
| T level | 1 month | T level is a electropsysiological value. It is the minimum electrical signal in the electrode required for the patient to sense sound. |
| C level | 1 month | C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound. |
| NRT level | 1 month | Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically. |
Countries
Denmark
Contacts
Primary ContactLeise Korsager, BSc
Outcome results
None listed