Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting

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Brief Title

Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting

Official Title

Evaluation of the Impact of a Tonotopy Based Fitting on the Speech and Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

Brief Summary

      Main objective:

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the perception speech in noise.

      Secondary objectives:

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the perception of musical elements (contour test).

      Show the non inferiority of tonotopy based fitting strategy compared to default fitting
      strategy on the perception of speech elements in quiet.

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the qualitative preference for the listening of musical pieces.
    

Detailed Description

      Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness,
      restoring speech perception and verbal communication when the traditional hearing aid no
      longer provides satisfactory hearing gain (Nimmons et al.).

      A cochlear implant includes an electrode array and its functioning is based on the principle
      of cochlear tonotopy: each electrode encodes a frequency spectrum according to its position
      in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to
      the apical electrodes).

      The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands
      via bandpass filters corresponding to the number of electrodes in the implant. During the
      fitting these bands can be modified by the audiologist.

      The fitting software developed by the manufacturers proposed a default fitting with a lower
      limit between 100 and 250 Hz according to the brands and an upper limit of about 8500 Hz. The
      frequency bands assigned to each electrode follow a logarithmic scale with the high
      frequencies for the basal electrodes and the low frequencies for the apical electrodes. This
      distribution takes into account the number of active electrodes but does not take into
      account the anatomy and the natural cochlear tonotopy specific to each patient.

      Several studies have analyzed the anatomical variations of the cochlear dimensions: size of
      the cochlea and the ratio between the contact surfaces of the electrodes with the cochlea are
      variable from one patient to another (Stakhovskaya O et al., P. Pelliccia et al.).

      The insertion depth during surgery is also variable due to parameters related to the patients
      as well as to the operator, which seems to impact the understanding of speech in noise (Deep
      electrode insertion and sound coding in cochlear implants - Ingeborg Hochmair et al.).

      Mathematical algorithms have recently been developed to estimate the cochlear tonotopy of
      each patient from a CT scan assessment (Jiam et al., Sridhar et al.). CT imaging of the
      implanted ear combined with 3D reconstruction software, provides cochlear length measurements
      (Cochlear length determination using Cone Beam Computed Tomography in a clinical setting -
      Würfel et al .) Using this approach it is possible to measure the position of each electrode
      relative to the cochlear apex. These measurements are applied to the modified Greenwood
      equation to obtain the tonotopic frequency for each electrode and to determine for each
      patient a fitting based on the tonotopy of each electrode.

      Main objective:

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the perception speech in noise.

      Secondary objectives:

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the perception of musical elements (contour test).

      Show the non inferiority of tonotopy based fitting strategy compared to default fitting
      strategy on the perception of speech elements in quiet.

      Show the superiority of tonotopy based fitting strategy compared to default fitting strategy
      on the qualitative preference for the listening of musical pieces.

      Plan of the study:

      It is a prospective open monocentric randomized crossover study: measures will be done on the
      patient at 6 weeks and 12 weeks post-activation.
    


Study Type

Interventional


Primary Outcome

speech recognition in noise

Secondary Outcome

 speech recognition in quiet

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

tonotopy based fitting then default fitting

Study Arms / Comparison Groups

 Cochlear Implant (CI) with default fitting then tonotopy based fitting
Description:  Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks

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

26

Start Date

June 10, 2021

Completion Date

September 30, 2021

Primary Completion Date

August 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patient (>= 18 years old) speaking French

          -  Patient who fulfils the criteria for cochlear implantation

        Exclusion Criteria:

          -  retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

          -  patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Benoit Godey, Pr, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04922619

Organization ID

MED_EL_tonofit_Rennes_study


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Benoit Godey, Pr, Principal Investigator, Rennes University Hospital


Verification Date

October 2021