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

NCT04192968 | Completed

• 2 other identifiers: APHP1908392019-A02402-55
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implantation

Keywords

Cochlear implantation; Automated cortical auditory evoked potentials; Speech-language therapy; Children; Cortical auditory evoked potentials; Electrical potentials via the implant

Outcome Measures

Primary Outcomes (2)

• Automated cortical auditory evoked potentials results

  Latency and amplitude of the waves P1, N1, P2, N2.

  Annual assessment performed during 3 years.

• Speech therapy result

  Percentage of recognition Open Set Words : * cochlear implant 1, * cochlear implant 2, * 2 cochlear implants together, * cochlear implant and hearing aid together.

  Annual assessment performed during 3 years.

Secondary Outcomes (12)

• Value of p (HearLab)

  Annual assessment performed during 3 years.

• Latencies P1, N1, P2, N2 (HearLab)

  Annual assessment performed during 3 years.

• Amplitudes P1, N1, P2, N2 (HearLab)

  Annual assessment performed during 3 years.

• Setting parameters

  Annual assessment performed during 3 years.

• Auditory rehabilitation

  Annual assessment performed during 3 years.

Study Arms (2)

Patients

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

Other: Cortical auditory evoked potentials

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.

Other: Additional exams

Interventions

Cortical auditory evoked potentials OTHER

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

Patients

Additional exams 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.

Patients with disappointing language development or poor cortical responses

Eligibility Criteria

• Age: 42 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children implanted for 3 years, in unilateral or bilateral and followed in the pediatric otolaryngology department of the Necker-Enfants Malades Hospital in Paris.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Natalie Loundon, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Isabelle Rouillon, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: January 13, 2020
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)