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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Deafness
• Intervention / Treatment: Procedure: bilateral cochlear Implantation in sequential; Procedure: bilateral cochlear Implantation in simultaneous

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: sequential; implantation bilateral sequential	Procedure: bilateral cochlear Implantation in sequential; bilateral cochlear Implantation in sequential
EXPERIMENTAL: simultaneous; implantation bilateral simultaneous	Procedure: bilateral cochlear Implantation in simultaneous; bilateral cochlear Implantation in simultaneous

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nathalie Loundon, MD, MD-PhD, Assistance Publique

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (ESTIMATE): December 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 19, 2012
• Last Update Submitted That Met QC Criteria: November 16, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: bilateral; auditory perception; deafness; unilateral implantation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: P091204; HAO 09048 (OTHER: Assistance Publique)