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

NCT ID: NCT04192968

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2024-04-13

Brief 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.

Detailed Description

Children with severe to profound deafness can benefit from cochlear rehabilitation, combined with a speech-language therapy. At present, 70 to 80% of children with congenital - profound deafness who are implanted at an early age will have a language level identical to their hearing peers. But 20 to 30% of them will be able to present linguistic difficulties.

The objective recording of the cortical activity in response to a sound stimulus gives a proof of the quality of the auditory stimulation that is perceived by the cortex, an essential condition for the further linguistic development of the child. By the use of complex stimuli of speeching type, all the channels involved in the auditory processing are analyzed.

The recording in routine clinical practice of the cortical auditory evoked potentials in response to a vocal stimulus makes it possible to objectify the quality of the auditory rehabilitation received by the child.

The implanted children all benefit from regular and prolonged speech therapy follow-up, with a complete evaluation every year. It is important to regularly monitor the linguistic evolution of young children who are implanted in order to identify children at risk of poorer linguistic development at an early age.

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 to 6 years post-implant by carrying out, during a visit scheduled for patient care, once a year for 3 years:

• Recording of automated cortical auditory evoked potentials in response to a vocal stimulus, as performed for the main study, but also :
• Recording of cortical auditory evoked potentials in response to a click
• Realization of electrical potentials via the implant And this in order to make it possible to objectify the quality of the auditory rehabilitation received by the child.

The objectives of the ancillary study are :

Comparison of the responses recorded to automated cortical auditory evoked potentials, of children who have had one or two cochlear implants for 4 years, with the results of speech therapy and up to 6 years post-implant.

Look for prognostic factors of poor linguistic development: correlate the electrophysiological results, the adjustment parameters, the modalities of hearing rehabilitation, the side of the cochlear implantation, and the audiometric thresholds with the results of the speech therapy assessment.

Conditions

Cochlear Implantation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Children implanted cochlear since 3 years in uni or bilateral and followed in the pediatric otolaryngology department of Necker-Enfants Malades Hospital.

Cortical auditory evoked potentials

Intervention Type: OTHER

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

Patients with disappointing language development or poor cortical responses

Children having participated in the main ImplantHear3 study and who present with disappointing language development or poor cortical responses.

Additional exams

Intervention Type: OTHER

• 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.

Interventions

Cortical auditory evoked potentials

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 42 months to 17 years on the day of inclusion.
• Patient who has received one or two cochlear implants between August 1, 2016 and November 1, 2017 and after 3 years of follow-up for the first implant.
• Non-opposition of the holders of the parental authority and the patient.

Exclusion Criteria

• Patients over 15 years of age at implantation.
• Patient relocated between August 1, 2016 and November 1, 2017.

• Minimum Eligible Age: 42 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Loundon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Isabelle Rouillon, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

Other Identifiers

2019-A02402-55

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190839

Identifier Type: -

Identifier Source: org_study_id