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