Clinical trial NCT01499901: Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children
Official title: Interest of the Bilateral Cochlear Implantation in the Deep Deaf Children Respect to the Unilateral Implantation - a Randomized Test
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Deafness
Keywords: deafness
unilateral implantation
bilateral
auditory perception
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement of the score of perception of words in open list
timeFrame: 12 months after the implantation
Secondary outcomes:
measure: Measurement of the capability of localization right/left
timeFrame: 12 and 24 months after the implantation
measure: Measurement of the level of comprehension and production
timeFrame: 24 months after the implantation
measure: Evaluation of the medical monitoring about the materiovigilance and the eventual complications
timeFrame: During all the duration of the study
measure: Measurement of the vestibulometry and of the children's psychomotor development
timeFrame: 12 and 24 months after the implantation
measure: Analysis of the parent questionnaires of the quality of life
timeFrame: 12 and 24 months after implantation
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique
name: Nathalie Loundon, MD, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: