Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients (NEUROSYLLABIC)

August 8, 2025 updated by: Hospices Civils de Lyon

Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon - Hôpital Édouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • native French speaker
  • no medical treatment for behavior or neurological disorders
  • normal or corrected vision
  • right-handed
  • normal ORL examination
  • valid affiliation to social security
  • absence of participation to another study

For the cochlear implanted patients:

  • aged from 1 to 70
  • bilateral severe to profound deafness
  • cochlear implant
  • congenital deafness, pre or post lingual

For the normal-hearing subjects:

  • Aged from 18 to 70
  • Normal tonal audiometry

Exclusion Criteria:

  • No signed consent
  • Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease
  • Physical health deficiency
  • Mental retardation
  • Neurological or psychiatric disease incompatible with the testing procedure
  • Schooling in a foreign language
  • Foreign language spoken at home with both parents
  • Invalid social security
  • For the normal hearing subjects, no known hearing deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: newly cochlear implanted adult patients
longitudinal group
Other: Auditory steady-state response ASSR
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Other: Speech-ABR
Other Names:
  • comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Other: Acoustic Change Complex ACC
comparison of ACC complex in response to changes within speech stimulation
Other: P1-N1-P2 complex and Mismatch Negativity MMN
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
Experimental: newly cochlear implanted children
longitudinal group
Other: Auditory steady-state response ASSR
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Other: Speech-ABR
Other Names:
  • comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Other: Acoustic Change Complex ACC
comparison of ACC complex in response to changes within speech stimulation
Other: P1-N1-P2 complex and Mismatch Negativity MMN
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
Active Comparator: cochlear implanted adult patients (CI>1 year)
transversal group
Other: Auditory steady-state response ASSR
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Other: Speech-ABR
Other Names:
  • comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Other: Acoustic Change Complex ACC
comparison of ACC complex in response to changes within speech stimulation
Other: P1-N1-P2 complex and Mismatch Negativity MMN
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
Active Comparator: normal hearing adult subjects
transversal group
Other: Auditory steady-state response ASSR
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Other: Speech-ABR
Other Names:
  • comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Other: Acoustic Change Complex ACC
comparison of ACC complex in response to changes within speech stimulation
Other: P1-N1-P2 complex and Mismatch Negativity MMN
comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amplitude of auditory steady state responses ASSR
Time Frame: one year at least after CI activation
one year at least after CI activation
Spectro-temporal analysis of speech-ABR
Time Frame: one year at least after CI activation
one year at least after CI activation
Acoustic Change Complex ACC
Time Frame: one year at least after CI activation
Amplitudes and latencies of ACC
one year at least after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Time Frame: one year at least after CI activation
one year at least after CI activation
Evolution of amplitude of auditory steady state responses ASSR
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of spectro-temporal analysis of speech-ABR
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Acoustic Change Complex ACC
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Time Frame: 1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients
1 month, 3 months, 6 months, 9 months and 12 months after CI activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014.857
  • 2014-A00345-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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