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

September 25, 2020 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • 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 Edouard 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

Ages Eligible for Study

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

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

Hospices Civils de Lyon

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)

July 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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