Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

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Brief Title

Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

Official Title

Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study

Brief Summary

      Main objective:

      Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody
      based solely on the frequency of the voice fundamental (F0) in speech

      Secondary objectives:

      Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of
      the results of differential frequency threshold test Evaluate the time evolution of vocal
      audiometric tests in silence and noise Evaluate the correlation between prosodic test results
      and frequency differential threshold results
    

Detailed Description

      Introduction:

      Prosodie is the study of the phenomena of accentuation and intonation (variation of pitch,
      duration and intensity) allowing the conveyance of information related to the sense such as
      the relief, but also the assertion, interrogation, injunction, exclamation ...

      It has a role at the grammatical, emotional and pragmatic levels of communication by
      informing about the emotional state of the speaker (sad / happy), about sex and identity,
      about the type of statement (question / affirmation) and about the borders in the sentences.

      The auditory cues that play a role in the perception of prosody include changes in the
      fundamental frequency F0 (ie vibrational frequency of the speaker's vocal cords) during a
      speech, the duration of the syllables, or the rate or intensity of the speech. [Di Christo
      2013] The cochlear implant is a device for auditory rehabilitation. Its principle is to
      transform the analog signals recorded by a microphone into digital signals that directly
      stimulate the fibers of the auditory nerve through electrodes inserted into the cochlea. [HAS
      2012, HAS 2007, http://www.has-sante.fr] Cochlear implants are indicated in cases of severe
      or profound sensorineural deafness.

      Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the
      electrode to code the frequency by sending low frequency information on the apical electrodes
      and high frequency information on the basal electrodes. The stimulation rate of the
      electrodes is constant. [Wilson & Dorman 2008] The pitch is only partially transmitted by
      these conventional strategies [Moore 2003; Oxenham 2008] which would explain the poor results
      of cochlear implants in the perception of music [Bruns & al. 2016; Galvin III & al. 2009;
      Veekmans & al. 2009; Cooper & al. 2008] and prosody [Kalathottukaren & al. 2015 ; Meister et
      al. 2011; Meister et al. 2009].

      In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the
      low-frequency electrodes is related to the frequency of the sound and makes it possible to
      code the frequency information temporally.

      [Rader & al. 2016] have studied the contribution of adding to the tonotopic coding of the
      frequency (classical strategy) a temporal coding of the information by varying the
      stimulation rate. The results obtained show that providing this frequency information by time
      coding makes it possible to obtain perceived pitch much closer to the expected pitch (of
      normal-hearing) and less variability, especially at low frequencies. With fixed stimulation
      rate (classical strategy) low frequencies are poorly coded, whereas with the variable
      stimulation rate they are better coded.

      The FineHearing coding strategy of MED-EL with long insertion of electrode could therefore
      make it possible to better transmit the prosody and specifically to better extract the
      fundamental frequency F0 of the voice.

      Objective of the study The objective of the study is to evaluate if the FineHearing strategy
      of the MED-EL implant allows to better transmit the prosody and specifically by the
      fundamental frequency of the voice (F0).

      Main objective:

      Show that the MED-EL FineHearing strategy (with deep insertion of the electrode) allows to
      extract prosody cues based only on the fundamental frequency F0.

      Secondary objectives:

        -  evaluate differential frequency thresholds and correlation with prosodic performance

        -  Evaluate the positioning of the electrode array and its effect on prosodic performance

      Plan of study:

      It is a prospective open multicenter longitudinal study: measures will be done on the patient
      at 6 and 12 month post-activation.
    


Study Type

Interventional


Primary Outcome

Prosodic test

Secondary Outcome

 Differential frequency threshold

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

FineHearing strategy

Study Arms / Comparison Groups

 CI with FineHearing Strategy
Description:  cochlear implant with FineHearing strategy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

February 28, 2019

Completion Date

February 28, 2021

Primary Completion Date

February 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patient with MED-EL cochlear implant (Sonnet / Synchrony)

          -  Adult patient (≥ 18 years old) speaking French

          -  Patient having an estimate of the optimal size of the electrode for its cochlea with
             the MED-EL software before their implantation.

          -  Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on
             250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)

          -  Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6
             months post-activation

        Exclusion criteria:

          -  Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mathieu Marx, Pr, (+33) 603592974, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03694704

Organization ID

MED-EL_FS_prosody_french_study


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Mathieu Marx, Pr, Principal Investigator, University Hospital, Toulouse


Verification Date

March 2020