Cochlear ImplantationImplantHear3NCT04192968
Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
An observational study of Cochlear Implantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 42 months to 17 years
- Conditions the study is for
- Cochlear Implantation
- What is being tested?
- Cortical auditory evoked potentials and Additional exams
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 13 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Patients over 15 years of age at implantation.
- Patient relocated between August 1, 2016 and November 1, 2017.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cochlear Implantation
- Being tested
- Cortical auditory evoked potentials, Additional exams
- Keywords
- Cochlear implantation, Automated cortical auditory evoked potentials, Speech-language therapy, Children, Cortical auditory evoked potentials, Electrical potentials via the implant
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical auditory evoked potentialsOther
Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
Additional examsOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Children implanted cochlear since 3 years in uni or bilateral and followed in the pediatric otolaryngology department of Necker-Enfants Malades Hospital. Receives: Other: Cortical auditory evoked potentials | |
| 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. Receives: Other: Additional exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated cortical auditory evoked potentials results
Latency and amplitude of the waves P1, N1, P2, N2.
Measured: Annual assessment performed during 3 years.
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.
Measured: Annual assessment performed during 3 years.
Secondary outcomes (12)
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.
Measured: Annual assessment performed during 3 years.
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.
Measured: 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.
Measured: Annual assessment performed during 3 years.
Setting parameters
Active electrode number, minimum thresholds and comfort, dynamic, on each side, pulse width and frequency.
Measured: 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),
- 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.
Measured: 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.
Measured: Annual assessment performed during the year of the 3 years following cochlear implantation.
Deafness characteristics
- age at the diagnosis,
- age at the beginning of deafness,
- etiology of the deafness,
- syndromic deafness or not.
Measured: 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)
Measured: 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)
Measured: Annual assessment performed during 3 years.
Latency study of the wave V
Electrical evoked potentials results via the implant
Measured: Annual assessment performed during 3 years.
Amplitude study of the wave V
Electrical evoked potentials results via the implant
Measured: Annual assessment performed during 3 years.
Stimulation level and pulse duration required to generate a wave V
Electrical evoked potentials results via the implant
Measured: Annual assessment performed during 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start13 Jan 2020
- Primary completion13 Apr 2024
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Natalie Loundon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisIsabelle Rouillon, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192968
- Sponsor's protocol ID
- APHP190839
- Other IDs
- 2019-A02402-55
- Acronym
- ImplantHear3
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
- ClinicalTrials.gov ID
- NCT04192968
- Acronym / sponsor ID
- ImplantHear3 / APHP190839
- Conditions
- Cochlear Implantation
- Keywords
- Cochlear implantation, Automated cortical auditory evoked potentials, Speech-language therapy, Children, Cortical auditory evoked potentials, Electrical potentials via the implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Cortical auditory evoked potentialsChildren 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 | – | Other: Additional examsChildren having participated in the main ImplantHear3 study and who present with disappointing language development or poor cortical responses. |
Who may qualify
- Ages
- 42 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients over 15 years of age at implantation.
- Patient relocated between August 1, 2016 and November 1, 2017.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortical auditory evoked potentialsRecording of automated cortical auditory evoked potentials in response to a vocal stimulus. | Other | Patients |
| 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. | Other | Patients with disappointing language development or poor cortical responses |
Primary outcome
Automated cortical auditory evoked potentials results
Time frame: Annual assessment performed during 3 years.
Latency and amplitude of the waves P1, N1, P2, N2.
Speech therapy result
Time frame: Annual assessment performed during 3 years.
Percentage of recognition Open Set Words : * cochlear implant 1, * cochlear implant 2, * 2 cochlear implants together, * cochlear implant and hearing aid together.
12 secondary outcomes
Value of p (HearLab)
Time frame: Annual assessment performed during 3 years.
Latencies P1, N1, P2, N2 (HearLab)
Time frame: Annual assessment performed during 3 years.
Amplitudes P1, N1, P2, N2 (HearLab)
Time frame: Annual assessment performed during 3 years.
Setting parameters
Time frame: Annual assessment performed during 3 years.
Auditory rehabilitation
Time frame: Annual assessment performed during 3 years.
Residual hearing level
Time frame: Annual assessment performed during the year of the 3 years following cochlear implantation.
Deafness characteristics
Time frame: Annual assessment performed during the year of the 3 years following cochlear implantation.
Latencies P1, N1, P2, N2
Time frame: Annual assessment performed during 3 years.
Amplitudes P1, N1, P2, N2
Time frame: Annual assessment performed during 3 years.
Latency study of the wave V
Time frame: Annual assessment performed during 3 years.
Amplitude study of the wave V
Time frame: Annual assessment performed during 3 years.
Stimulation level and pulse duration required to generate a wave V
Time frame: Annual assessment performed during 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Loundon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Isabelle Rouillon, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automated cortical auditory evoked potentials results (time frame: Annual assessment performed during 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.