Cochlear Implant and Vestibular Function.

Odense University Hospital

Status: Unknown

Conditions: Hearing Loss; Deafness; Sensorineural Hearing Loss

Treatments: Procedure: Cochleostomy; Procedure: Round window approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02584361

47190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Cochleostomy

Active Comparator group

Description:

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

Treatment:

Procedure: Cochleostomy

Round window approach

Active Comparator group

Description:

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)

Treatment:

Procedure: Round window approach