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

Deafness Clinical Trial

— Cochleo  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01499901
• Other study ID #: P091204
• Secondary ID: HAO 09048
• Status: Withdrawn
• Phase: Phase 3
• First received: December 6, 2011
• Last updated: November 16, 2012
• Start date: January 2012
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Months to 38 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness

Intervention

Procedure:
• bilateral cochlear Implantation in sequential
bilateral cochlear Implantation in sequential
• bilateral cochlear Implantation in simultaneous
bilateral cochlear Implantation in simultaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of the capability of localization right/left	Measurement of the capability of localization right/left	12 and 24 months after the implantation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No