Clinical trial NCT04192968: Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Official title: Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implantation
Keywords: Cochlear implantation
Automated cortical auditory evoked potentials
Speech-language therapy
Children
Cortical auditory evoked potentials
Electrical potentials via the implant
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 42
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Automated cortical auditory evoked potentials results
timeFrame: Annual assessment performed during 3 years.
measure: Speech therapy result
timeFrame: Annual assessment performed during 3 years.
Secondary outcomes:
measure: Value of p (HearLab)
timeFrame: Annual assessment performed during 3 years.
measure: Latencies P1, N1, P2, N2 (HearLab)
timeFrame: Annual assessment performed during 3 years.
measure: Amplitudes P1, N1, P2, N2 (HearLab)
timeFrame: Annual assessment performed during 3 years.
measure: Setting parameters
timeFrame: Annual assessment performed during 3 years.
measure: Auditory rehabilitation
timeFrame: Annual assessment performed during 3 years.
measure: Residual hearing level
timeFrame: Annual assessment performed during the year of the 3 years following cochlear implantation.
measure: Deafness characteristics
timeFrame: Annual assessment performed during the year of the 3 years following cochlear implantation.
measure: Latencies P1, N1, P2, N2
timeFrame: Annual assessment performed during 3 years.
measure: Amplitudes P1, N1, P2, N2
timeFrame: Annual assessment performed during 3 years.
measure: Latency study of the wave V
timeFrame: Annual assessment performed during 3 years.
measure: Amplitude study of the wave V
timeFrame: Annual assessment performed during 3 years.
measure: Stimulation level and pulse duration required to generate a wave V
timeFrame: Annual assessment performed during 3 years.
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natalie Loundon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Rouillon, MD
role: STUDY_DIRECTOR
References: