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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT02323256
Collaborator
(none)
91
Enrollment
1
Location
4
Arms
46
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Auditory steady-state response ASSR
  • Other: Speech-ABR
  • Other: Acoustic Change Complex ACC
  • Other: P1-N1-P2 complex and Mismatch Negativity MMN
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Amplitude of auditory steady state responses ASSR [one year at least after CI activation]

    2. Spectro-temporal analysis of speech-ABR [one year at least after CI activation]

    3. Acoustic Change Complex ACC [one year at least after CI activation]

      Amplitudes and latencies of ACC

    4. amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN [one year at least after CI activation]

    5. Evolution of amplitude of auditory steady state responses ASSR [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

    6. Evolution of spectro-temporal analysis of speech-ABR [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

    7. Acoustic Change Complex ACC [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

    8. amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospices Civils de Lyon - Hopital Edouard Herriot Lyon France 69003

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT02323256
    Other Study ID Numbers:
    • 2014.857
    • 2014-A00345-42
    First Posted:
    Dec 23, 2014
    Last Update Posted:
    Sep 28, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Hospices Civils de Lyon
    cochlear implant
    deafness
    audiometry
    speech perception
    severe to profound deafness restored with cochlear implantation
    Additional relevant MeSH terms:
    Deafness
    Hearing Loss

    Study Results

    No Results Posted as of Sep 28, 2020