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

Primary Purpose

Deafness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auditory steady-state response ASSR
Speech-ABR
Acoustic Change Complex ACC
P1-N1-P2 complex and Mismatch Negativity MMN
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Deafness focused on measuring cochlear implant, deafness, audiometry, speech perception, severe to profound deafness restored with cochlear implantation

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospices Civils de Lyon - Hopital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

newly cochlear implanted adult patients

newly cochlear implanted children

cochlear implanted adult patients (CI>1 year)

normal hearing adult subjects

Arm Description

longitudinal group

longitudinal group

transversal group

transversal group

Outcomes

Primary Outcome Measures

Amplitude of auditory steady state responses ASSR
Spectro-temporal analysis of speech-ABR
Acoustic Change Complex ACC
Amplitudes and latencies of ACC
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Evolution of amplitude of auditory steady state responses ASSR
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
Evolution of spectro-temporal analysis of speech-ABR
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
Acoustic Change Complex ACC
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
September 25, 2020
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02323256
Brief Title
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
Acronym
NEUROSYLLABIC
Official Title
Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
cochlear implant, deafness, audiometry, speech perception, severe to profound deafness restored with cochlear implantation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
newly cochlear implanted adult patients
Arm Type
Experimental
Arm Description
longitudinal group
Arm Title
newly cochlear implanted children
Arm Type
Experimental
Arm Description
longitudinal group
Arm Title
cochlear implanted adult patients (CI>1 year)
Arm Type
Active Comparator
Arm Description
transversal group
Arm Title
normal hearing adult subjects
Arm Type
Active Comparator
Arm Description
transversal group
Intervention Type
Other
Intervention Name(s)
Auditory steady-state response ASSR
Intervention Description
comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
Intervention Type
Other
Intervention Name(s)
Speech-ABR
Other Intervention Name(s)
comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Intervention Type
Other
Intervention Name(s)
Acoustic Change Complex ACC
Intervention Description
comparison of ACC complex in response to changes within speech stimulation
Intervention Type
Other
Intervention Name(s)
P1-N1-P2 complex and Mismatch Negativity MMN
Intervention Description
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
Primary Outcome Measure Information:
Title
Amplitude of auditory steady state responses ASSR
Time Frame
one year at least after CI activation
Title
Spectro-temporal analysis of speech-ABR
Time Frame
one year at least after CI activation
Title
Acoustic Change Complex ACC
Description
Amplitudes and latencies of ACC
Time Frame
one year at least after CI activation
Title
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Time Frame
one year at least after CI activation
Title
Evolution of amplitude of auditory steady state responses ASSR
Description
Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients
Time Frame
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Title
Evolution of spectro-temporal analysis of speech-ABR
Description
Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients
Time Frame
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Title
Acoustic Change Complex ACC
Description
Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients
Time Frame
1 month, 3 months, 6 months, 9 months and 12 months after CI activation
Title
amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN
Description
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
Time Frame
1 month, 3 months, 6 months, 9 months and 12 months after CI activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon - Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

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