Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Primary Purpose
Sensorineural Hearing Loss, Bilateral
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FineHearing strategy or HDCIS strategy
Sponsored by
About this trial
This is an interventional other trial for Sensorineural Hearing Loss, Bilateral focused on measuring cochlear implant stimulation strategy sound coding strategy
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
Sites / Locations
- CHU Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cochlear implant (CI) with FineHearing Strategy then HDCIS
CI with HDCIS Strategy then FS4
Arm Description
cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days
cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days
Outcomes
Primary Outcome Measures
Qualitative measure of music
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
Qualitative measure of music
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
Secondary Outcome Measures
Speech recognition in quiet
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Speech recognition in quiet
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Melodic contour test
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Melodic contour test
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Full Information
NCT ID
NCT03993899
First Posted
June 19, 2019
Last Updated
January 7, 2020
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
1. Study Identification
Unique Protocol Identification Number
NCT03993899
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 7, 2020 (Actual)
Study Completion Date
January 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MED-EL Elektromedizinische Geräte GesmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral
Keywords
cochlear implant stimulation strategy sound coding strategy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
two arms A and B:
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
Masking
ParticipantInvestigator
Masking Description
Double blind study: the patient and the investigator don't know the strategy
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cochlear implant (CI) with FineHearing Strategy then HDCIS
Arm Type
Active Comparator
Arm Description
cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days
Arm Title
CI with HDCIS Strategy then FS4
Arm Type
Active Comparator
Arm Description
cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days
Intervention Type
Device
Intervention Name(s)
FineHearing strategy or HDCIS strategy
Intervention Description
Cochlear implant with FineHearing strategy or HDCIS strategy
Primary Outcome Measure Information:
Title
Qualitative measure of music
Description
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
Time Frame
at 15 days post-activation
Title
Qualitative measure of music
Description
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
Time Frame
at 30 days post-activation
Secondary Outcome Measure Information:
Title
Speech recognition in quiet
Description
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Time Frame
at 15 days post-activation
Title
Speech recognition in quiet
Description
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Time Frame
at 30 days post-activation
Title
Differential frequency threshold
Description
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Time Frame
at 15 days post-activation
Title
Differential frequency threshold
Description
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Time Frame
at 30 days post-activation
Title
Melodic contour test
Description
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Time Frame
at 15 days post-activation
Title
Melodic contour test
Description
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Time Frame
at 30 days post-activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Godey, Pr
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
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