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

Primary Purpose

Deafness

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bilateral cochlear Implantation in sequential
bilateral cochlear Implantation in simultaneous
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness focused on measuring deafness, unilateral implantation, bilateral, auditory perception

Eligibility Criteria

8 Months - 38 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    sequential

    simultaneous

    Arm Description

    implantation bilateral sequential

    implantation bilateral simultaneous

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Measurement of the capability of localization right/left
    Measurement of the capability of localization right/left
    Measurement of the level of comprehension and production
    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
    Evaluation of the medical monitoring about the materiovigilance and the eventual complications
    Measurement of the vestibulometry and of the children's psychomotor development
    Measurement of the vestibulometry and of the children's psychomotor development
    Analysis of the parent questionnaires of the quality of life
    Analysis of the parent questionnaires of the quality of life

    Full Information

    First Posted
    December 6, 2011
    Last Updated
    November 16, 2012
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01499901
    Brief Title
    Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children
    Acronym
    Cochleo
    Official Title
    Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recommendations of HAS have changed, the study is now useless
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deafness
    Keywords
    deafness, unilateral implantation, bilateral, auditory perception

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sequential
    Arm Type
    Experimental
    Arm Description
    implantation bilateral sequential
    Arm Title
    simultaneous
    Arm Type
    Experimental
    Arm Description
    implantation bilateral simultaneous
    Intervention Type
    Procedure
    Intervention Name(s)
    bilateral cochlear Implantation in sequential
    Intervention Description
    bilateral cochlear Implantation in sequential
    Intervention Type
    Procedure
    Intervention Name(s)
    bilateral cochlear Implantation in simultaneous
    Intervention Description
    bilateral cochlear Implantation in simultaneous
    Primary Outcome Measure Information:
    Title
    Measurement of the score of perception of words in open list
    Description
    Measurement of the score of perception of words in open list in the noise 12 and 24 months after the implantation
    Time Frame
    12 months after the implantation
    Secondary Outcome Measure Information:
    Title
    Measurement of the capability of localization right/left
    Description
    Measurement of the capability of localization right/left
    Time Frame
    12 and 24 months after the implantation
    Title
    Measurement of the level of comprehension and production
    Description
    Measurement of the level of comprehension and production after 24 months after the implantation
    Time Frame
    24 months after the implantation
    Title
    Evaluation of the medical monitoring about the materiovigilance and the eventual complications
    Description
    Evaluation of the medical monitoring about the materiovigilance and the eventual complications
    Time Frame
    During all the duration of the study
    Title
    Measurement of the vestibulometry and of the children's psychomotor development
    Description
    Measurement of the vestibulometry and of the children's psychomotor development
    Time Frame
    12 and 24 months after the implantation
    Title
    Analysis of the parent questionnaires of the quality of life
    Description
    Analysis of the parent questionnaires of the quality of life
    Time Frame
    12 and 24 months after implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Months
    Maximum Age & Unit of Time
    38 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nathalie Loundon, MD, MD-PhD
    Organizational Affiliation
    Assistance Publique
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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