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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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).
In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Odense University Hospital
Odense, DK-Odense, Denmark
RECRUITINGVestibular function
Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation
Time frame: 1 month
Subjective dizziness
Measured by Dizziness Handicap Inventory Score (DHI).
Time frame: 1 month
Dizziness
Measured by a visuel analog scale (VAS) the day after cochlear implant surgery.
Time frame: 1 day
Dizziness
Measured by a visuel analog scale (VAS) in connection with consultation for CI activation.
Time frame: 1 month
T level
T level is a electropsysiological value. It is the minimum electrical signal in the electrode required for the patient to sense sound.
Time frame: 1 month
C level
C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound.
Time frame: 1 month
NRT level
Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.