Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
Study NCT ID:
NCT04192968
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImplantHear3
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A02402-55 | OTHER | ID RCB number | View |