Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

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Brief Title

Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

Official Title

Evaluation of the Impact of Coding the Fine Structure of the Sound on the Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

Brief Summary

      Main objective:

      Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved
      Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.

      Secondary objectives

        -  Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of
           musical elements (contour test).

        -  Analyze the link between the results of musical perception tests and the subjective
           preference of musical listening.

        -  Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the
           perception of speech elements.

        -  Analyze the link between the results of musical perception tests and the results of the
           perception of speech elements.

        -  Analyze the qualitative multidimensional perception with HDCIS and FS4
    

Detailed Description

      Introduction:

      At present, most people with modern cochlear implant systems can understand speech using the
      device alone, at least under favorable listening conditions.

      In recent years, research has increasing focussed on how implant users perceive sounds other
      than speech. In particular, music perception is of interest.

      A review of the literature on musical perception with traditional implants, coding only the
      temporal envelope [McDermott 2004], revealed the following elements:

        -  On average, implant users perceive the rhythm approximately as well as listeners with
           normal hearing

        -  With technically sophisticated multi-channel sound processors, melody recognition,
           especially without rhythmic or verbal cues, is poor.

        -  The perception of timbre, especially the sounds of musical instruments, is generally
           unsatisfactory.

        -  Implant users tend to rate the quality of musical sounds as less enjoyable than
           listeners with normal hearing And studies show that the fine structure of sound is the
           main vector of information for music and the location of sounds. [Smith et al. 2002] It
           therefore seems necessary to focus on the contribution of the coding of the fine
           temporal structure of sound to the cochlear implant.

      Main objective:

      Show the superiority of FS4 strategy compared to HDCIS strategy on the qualitative preference
      for the listening of musical pieces.

      Secondary objectives:

        -  Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of
           musical elements (contour test).

        -  Analyze the link between the results of musical perception tests and the subjective
           preference of musical listening.

        -  Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the
           perception of speech elements.

        -  Analyze the link between the results of musical perception tests and the results of the
           perception of speech elements.

        -  Analyze the qualitative multidimensional perception with HDCIS and FS4

      Plan of the study:

      It is a prospective open monocentric randomized crossover study: measures will be done on the
      patient at 15 days and 30 days post-activation.
    


Study Type

Interventional


Primary Outcome

Qualitative measure of music

Secondary Outcome

 Speech recognition in quiet

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

FineHearing strategy or HDCIS strategy

Study Arms / Comparison Groups

 Cochlear implant (CI) with FineHearing Strategy then HDCIS
Description:  cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days

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

19

Start Date

July 1, 2019

Completion Date

January 7, 2020

Primary Completion Date

January 7, 2020

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
      

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

NCT03993899

Organization ID

MED_EL_FS_music_Rennes_study


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Benoit Godey, Pr, Principal Investigator, Rennes University Hospital


Verification Date

January 2020