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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02402-55 | Other Identifier | ID RCB number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Children implanted cochlear since 3 years in uni or bilateral and followed in the pediatric otolaryngology department of Necker-Enfants Malades Hospital. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cortical auditory evoked potentials | Other | Recording of automated cortical auditory evoked potentials in response to a vocal stimulus. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| Annual assessment performed during 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Latencies P1, N1, P2, N2 (HearLab) |
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Inclusion Criteria:
Exclusion Criteria:
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Children implanted for 3 years, in unilateral or bilateral and followed in the pediatric otolaryngology department of the Necker-Enfants Malades Hospital in Paris.
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Loundon, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Isabelle Rouillon, MD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Additional exams | Other |
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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. |
| 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. |
| Setting parameters | Active electrode number, minimum thresholds and comfort, dynamic, on each side, pulse width and frequency. | Annual assessment performed during 3 years. |
| 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),
| Annual assessment performed during 3 years. |
| 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. |
| Deafness characteristics |
| Annual assessment performed during the year of the 3 years following cochlear implantation. |
| 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. |
| 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. |
| Latency study of the wave V | Electrical evoked potentials results via the implant | Annual assessment performed during 3 years. |
| Amplitude study of the wave V | Electrical evoked potentials results via the implant | Annual assessment performed during 3 years. |
| Stimulation level and pulse duration required to generate a wave V | Electrical evoked potentials results via the implant | Annual assessment performed during 3 years. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |