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Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results

NCT04192968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-09-12

No results posted yet for this study

Summary

The objective of the study is to compare the responses recorded with automated cortical auditory evoked potentials, of children who had one or two cochlear implants for 3 years, and the results of the speech therapy assessment.

24 patients in the main ImplantHear3 study presented with disappointing language development or poor cortical responses. These patients will be followed up once a year, during a visit scheduled for the usual care, until 6 years post-implant, in order to make it possible to objectify the quality of the auditory rehabilitation received by the child.

Conditions

  • Cochlear Implantation

Interventions

OTHER

Cortical auditory evoked potentials

Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.

OTHER

Additional exams

* Cortical auditory evoked potentials Recording of automated cortical auditory evoked potentials in response to a vocal stimulus. * Recording of cortical auditory evoked potentials in response to a click * Realization of electrical potentials via the implant Followed up once a year during a visit scheduled for usual care, for 3 years, that to say up to 6 years post-implant.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Natalie Loundon, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Isabelle Rouillon, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
42 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2024-04-13
Completion
2024-04-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192968 on ClinicalTrials.gov