Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
NCT ID: NCT03993899
Last Updated: 2020-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2019-07-01
2020-01-07
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Arm A: patient's fitting with strategy FS4 --\> 15 days use --\> tests and patient's fitting with strategy HDCIS --\> 15 days use --\> tests
Arm B: patient's fitting with strategy HDCIS --\> 15 days use --\> tests and patient's fitting with strategy FS4 --\> 15 days use --\> tests
OTHER
DOUBLE
Study Groups
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Cochlear implant (CI) with FineHearing Strategy then HDCIS
cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days
FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
CI with HDCIS Strategy then FS4
cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days
FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
Interventions
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FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
Eligibility Criteria
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Inclusion Criteria
* Patient who fulfils the criteria for cochlear implantation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Benoit Godey, Pr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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CHU Rennes
Rennes, , France
Countries
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Other Identifiers
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MED_EL_FS_music_Rennes_study
Identifier Type: -
Identifier Source: org_study_id
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