Cochlear Implant and Vestibular Function.

Not Applicable

• Conditions: Hearing Loss; Deafness; Sensorineural Hearing Loss
• Interventions: Procedure: Cochleostomy; Procedure: Round window approach

• Registration Number: NCT02584361
• Lead Sponsor: Odense University Hospital

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-31
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• deaf or severe hard of hearing
• normal or slightly affected vestibular function (gain >0,50)

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Exclusion Criteria

• subjects with otosclerosis
• subject who will have the CI surgery for preservation of the residual hearing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cochleostomy	Cochleostomy	In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
Round window approach	Round 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)

Primary Outcome Measures

Name	Time	Method
Vestibular function	1 month	Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation

Secondary Outcome Measures

Name	Time	Method
Subjective dizziness	1 month	Measured by Dizziness Handicap Inventory Score (DHI).
Dizziness	1 month	Measured by a visuel analog scale (VAS) in connection with consultation for CI activation.
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.
NRT level	1 month	Neural response telemetry, is an electrical response of the auditory nerve, when stimulated electrically.
C level	1 month	C level is the maximum electrical signal in the electrode that is acceptable for the patient to tolerate the sound.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, DK-Odense, Denmark