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

Primary Purpose

Sensorineural Hearing Loss, Bilateral

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tonotopy based fitting then default fitting
default fitting then tonotopy based fitting
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sensorineural Hearing Loss, Bilateral focused on measuring cochlear implant strategy, tonotopy based fitting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cochlear Implant (CI) with default fitting then tonotopy based fitting

Cochlear Implant (CI) with tonotopy based fitting then default fitting

Arm Description

Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks

Cochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks

Outcomes

Primary Outcome Measures

speech recognition in noise
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
speech recognition in noise
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

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 20 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 20 syllables. The phonemes are scored: 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 correspond 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 correspond 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%).
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 sound, 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 sound, 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).

Full Information

First Posted
June 2, 2021
Last Updated
October 19, 2021
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04922619
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (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 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.

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 strategy, tonotopy based fitting

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 default fitting --> 6 weeks use --> tests and patient's fitting with tonotopy based fitting --> 6 weeks use --> tests Arm B: patient's fitting with tonotopy based fitting --> 6 weeks use --> tests and patient's fitting with default fitting --> 6 weeks use --> tests
Masking
ParticipantInvestigator
Masking Description
Double blind study: the patient and the investigator don't know the fitting.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implant (CI) with default fitting then tonotopy based fitting
Arm Type
Active Comparator
Arm Description
Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks
Arm Title
Cochlear Implant (CI) with tonotopy based fitting then default fitting
Arm Type
Active Comparator
Arm Description
Cochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks
Intervention Type
Device
Intervention Name(s)
tonotopy based fitting then default fitting
Intervention Description
Cochlear implant with default fitting then tonotopy based fitting
Intervention Type
Device
Intervention Name(s)
default fitting then tonotopy based fitting
Intervention Description
Cochlear implant with tonotopy based fitting then default fitting
Primary Outcome Measure Information:
Title
speech recognition in noise
Description
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
Time Frame
at 6 weeks post-activation
Title
speech recognition in noise
Description
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
Time Frame
at 12 weeks 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 20 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 6 weeks 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 20 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 12 weeks 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 correspond 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 6 weeks 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 correspond 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 12 weeks 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 sound, 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 6 weeks 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 sound, 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 12 weeks 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 patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz
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 Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting

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