Hôpital Necker-Enfants Malades
Paris, 75015, France
NCT Number: NCT04192968
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.
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Notify Me42 month–17 year
All sexes
Observational
Paris, 75015, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
Time frame: Annual assessment performed during 3 years.
Latency and amplitude of the waves P1, N1, P2, N2.
Time frame: Annual assessment performed during 3 years.
Percentage of recognition Open Set Words :
Time frame: Annual assessment performed during 3 years.
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.
Time frame: Annual assessment performed during 3 years.
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.
Time frame: Annual assessment performed during 3 years.
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.
Time frame: Annual assessment performed during 3 years.
Active electrode number, minimum thresholds and comfort, dynamic, on each side, pulse width and frequency.
Time frame: Annual assessment performed during 3 years.
Time frame: Annual assessment performed during the year of the 3 years following cochlear implantation.
Auditory level without devices :
right Ear : 250, 500, 1000, 2000, 4000 Hz, left Ear : 250, 500, 1000, 2000, 4000 Hz.
Time frame: Annual assessment performed during the year of the 3 years following cochlear implantation.
Time frame: Annual assessment performed during 3 years.
Study of the latencies P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)
Time frame: Annual assessment performed during 3 years.
Study of the amplitudes P1, N1, P2, N2 by cortical auditory evoked potentials results (in response to click)
Time frame: Annual assessment performed during 3 years.
Electrical evoked potentials results via the implant
Time frame: Annual assessment performed during 3 years.
Electrical evoked potentials results via the implant
Time frame: Annual assessment performed during 3 years.
Electrical evoked potentials results via the implant
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ImplantHear3
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