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Completed

NCT Number: NCT02323256

Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients

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.

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Key information

Conditions

Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hopital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory steady-state response ASSR

Other

comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities

Speech-ABR

Other

Other names: comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables

Acoustic Change Complex ACC

Other

comparison of ACC complex in response to changes within speech stimulation

P1-N1-P2 complex and Mismatch Negativity MMN

Other

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 outcomes

  1. Amplitude of auditory steady state responses ASSR

    Time frame: one year at least after CI activation

  2. Spectro-temporal analysis of speech-ABR

    Time frame: one year at least after CI activation

  3. Acoustic Change Complex ACC

    Time frame: 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

    Time frame: one year at least after CI activation

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: NEUROSYLLABIC

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2014
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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