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

Cochlear Implantation Clinical Trial

— ImplantHear3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192968
• Other study ID #: APHP190839
• Secondary ID: 2019-A02402-55
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: April 13, 2024

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 13, 2024
• Est. primary completion date: April 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implantation

Intervention

Other:
• Cortical auditory evoked potentials
Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
• 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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Automated cortical auditory evoked potentials results	Latency and amplitude of the waves P1, N1, P2, N2.	Annual assessment performed during 3 years.
Primary	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	Value of p (HearLab)	Analysis of the automatic validation by HearLab: value of p, for each vocal stimulus / m /, / g /, / t /, and / s / as a function of the intensity : 55, 65, 75 Db.	Annual assessment performed during 3 years.
Secondary	Latencies P1, N1, P2, N2 (HearLab)	Study of the latencies P1, N1, P2, N2 by HearLab, as a function of the stimulus / m /, / g /, / t /, and / s /, intensity : 55, 65, 75 dB and age.	Annual assessment performed during 3 years.
Secondary	Amplitudes P1, N1, P2, N2 (HearLab)	Study of the amplitudes P1, N1, P2, N2 by HearLab, as a function of the stimulus / m /, / g /, / t /, and / s /, intensity : 55, 65, 75 dB and age.	Annual assessment performed during 3 years.
Secondary	Setting parameters	Active electrode number, minimum thresholds and comfort, dynamic, on each side, pulse width and frequency.	Annual assessment performed during 3 years.
Secondary	Auditory rehabilitation	- Type of auditory rehabilitation : uni or bilateral cochlear implant : if bilateral cochlear implant : sequential or simultaneous, if unilateral cochlear implant : side, contralateral hearing aid (yes or no),; age at implantation (for each side if bilateral); cochlear implant Device; electrode; datalogging for each cochlear implant : never/ <6 hours/ 6-9hours/>10 hours,; hearing aid device.	Annual assessment performed during 3 years.
Secondary	Residual hearing level	Auditory level without devices : right Ear : 250, 500, 1000, 2000, 4000 Hz, left Ear : 250, 500, 1000, 2000, 4000 Hz.	Annual assessment performed during the year of the 3 years following cochlear implantation.
Secondary	Deafness characteristics	age at the diagnosis,; age at the beginning of deafness,; etiology of the deafness,; syndromic deafness or not.	Annual assessment performed during the year of the 3 years following cochlear implantation.
Secondary	Latencies P1, N1, P2, N2	Study of the latencies P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)	Annual assessment performed during 3 years.
Secondary	Amplitudes P1, N1, P2, N2	Study of the amplitudes P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)	Annual assessment performed during 3 years.
Secondary	Latency study of the wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.
Secondary	Amplitude study of the wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.
Secondary	Stimulation level and pulse duration required to generate a wave V	Electrical evoked potentials results via the implant	Annual assessment performed during 3 years.