Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children

Study Overview
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Brief Summary
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In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.

Detailed Description
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French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life.

Official Title
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Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test

Conditions
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Deafness

Intervention / Treatment
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* Procedure: bilateral cochlear Implantation in sequential
* Procedure: bilateral cochlear Implantation in simultaneous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deep bilateral congenital deafness. Age at the implantation: from 10 to 40 months, included. Criteria for indication of unilateral implantation (those considered by the HAS (2007)) Deep bilateral deafness Threshold prosthetic equal or above 60 dB Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus) No medical nor radiologic contraindication Entitled child for welfare (excepted medical state aids) French spoken at home Agreement firms for the study by the two genitors Exclusion Criteria: Neurologic and/or psychiatric known related disorders Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation. Progressive or acquired deafness

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 38 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sequential<br>implantation bilateral sequential | Procedure: bilateral cochlear Implantation in sequential<br>* bilateral cochlear Implantation in sequential<br>|
| Experimental: simultaneous<br>implantation bilateral simultaneous | Procedure: bilateral cochlear Implantation in simultaneous<br>* bilateral cochlear Implantation in simultaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the score of perception of words in open list | Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation | 12 months after the implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the capability of localization right/left | Measurement of the capability of localization right/left | 12 and 24 months after the implantation | 
| Measurement of the level of comprehension and production | Measurement of the level of comprehension and production after 24 months after the implantation | 24 months after the implantation | 
| Evaluation of the medical monitoring about the materiovigilance and the eventual complications | Evaluation of the medical monitoring about the materiovigilance and the eventual complications | During all the duration of the study | 
| Measurement of the vestibulometry and of the children's psychomotor development | Measurement of the vestibulometry and of the children's psychomotor development | 12 and 24 months after the implantation | 
| Analysis of the parent questionnaires of the quality of life | Analysis of the parent questionnaires of the quality of life | 12 and 24 months after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deafness, unilateral implantation, bilateral, auditory perception