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

NCT ID: NCT01499901

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-01-31

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.

Conditions

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Deafness

Keywords

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deafness unilateral implantation bilateral auditory perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequential

implantation bilateral sequential

Group Type EXPERIMENTAL

bilateral cochlear Implantation in sequential

Intervention Type PROCEDURE

bilateral cochlear Implantation in sequential

simultaneous

implantation bilateral simultaneous

Group Type EXPERIMENTAL

bilateral cochlear Implantation in simultaneous

Intervention Type PROCEDURE

bilateral cochlear Implantation in simultaneous

Interventions

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bilateral cochlear Implantation in sequential

bilateral cochlear Implantation in sequential

Intervention Type PROCEDURE

bilateral cochlear Implantation in simultaneous

bilateral cochlear Implantation in simultaneous

Intervention Type PROCEDURE

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
Minimum Eligible Age

8 Months

Maximum Eligible Age

38 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Loundon, MD, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Countries

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France

Other Identifiers

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HAO 09048

Identifier Type: OTHER

Identifier Source: secondary_id

P091204

Identifier Type: -

Identifier Source: org_study_id