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

Phase 3

Withdrawn

• Conditions: Deafness
• Interventions: Procedure: bilateral cochlear Implantation in sequential; Procedure: bilateral cochlear Implantation in simultaneous

• Registration Number: NCT01499901
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Study Start: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sequential	bilateral cochlear Implantation in sequential	implantation bilateral sequential
simultaneous	bilateral cochlear Implantation in simultaneous	implantation bilateral simultaneous

Primary Outcome Measures

Name	Time	Method
Measurement of the score of perception of words in open list	12 months after the implantation	Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation

Secondary Outcome Measures

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