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

This study has been withdrawn prior to enrollment.
(Recommendations of HAS have changed, the study is now useless)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01499901
First received: December 6, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Deafness
 Procedure: bilateral cochlear Implantation in sequential
Procedure: bilateral cochlear Implantation in simultaneous
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Measurement of the score of perception of words in open list [ Time Frame: 12 months after the implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months after the implantation ] [ Designated as safety issue: No ]
    Measurement of the capability of localization right/left

  • Measurement of the level of comprehension and production [ Time Frame: 24 months after the implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: During all the duration of the study ] [ Designated as safety issue: No ]
    Evaluation of the medical monitoring about the materiovigilance and the eventual complications

  • Measurement of the vestibulometry and of the children's psychomotor development [ Time Frame: 12 and 24 months after the implantation ] [ Designated as safety issue: No ]
    Measurement of the vestibulometry and of the children's psychomotor development

  • Analysis of the parent questionnaires of the quality of life [ Time Frame: 12 and 24 months after implantation ] [ Designated as safety issue: No ]
    Analysis of the parent questionnaires of the quality of life


Enrollment: 0
Study Start Date: January 2012
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sequential
implantation bilateral sequential
 Procedure: bilateral cochlear Implantation in sequential
bilateral cochlear Implantation in sequential
Other Name: bilateral cochlear Implantation in sequential
Experimental: simultaneous
implantation bilateral simultaneous
 Procedure: bilateral cochlear Implantation in simultaneous
bilateral cochlear Implantation in simultaneous
Other Name: 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.

  Eligibility

Ages Eligible for Study:   8 Months to 38 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499901

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie Loundon, MD, MD-PhD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01499901     History of Changes
Other Study ID Numbers: P091204, HAO 09048
Study First Received: December 6, 2011
Last Updated: November 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
deafness
unilateral implantation
bilateral
auditory perception

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013