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Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

Primary Purpose

Sensorineural Hearing Loss, Bilateral

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
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, stimulation strategy, sound coding strategy

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
  • Patient with a postoperative insertion angle of the apical electrode > 450°
  • Patient with 12 active electrodes on the day of activation.

Exclusion Criteria:

  • Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sites / Locations

  • GH Pitié-Salpêtrière, APHP 6Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated

CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated

Arm Description

Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month

Cochlear implant with FineHearing Strategy with 10 more basal electrodes activated first during 1 month then FineHearing Strategy with 10 more apical electrodes activated during 1 month

Outcomes

Primary Outcome Measures

Qualitative measure of music with direct audio link
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). The test is performed with a direct audio link to the CI.
Qualitative measure of music with direct audio link
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). The test is performed with a direct audio link to the CI.

Secondary 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). The test is performed in free field without any contralateral aid.
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). The test is performed in free field without any contralateral aid.
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Speech recognition in quiet
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (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.
Sound quality
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.
Sound quality
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.

Full Information

First Posted
October 11, 2020
Last Updated
August 14, 2023
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04591093
Brief Title
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Official Title
Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

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: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater. Secondary objectives: Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
Detailed Description
Introduction: Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes. The stimulation rate of the electrodes is constant. The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music. In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally. Rader & al. 2016 have studied the contribution of adding to the tonotopic coding of the frequency (classical strategy) a temporal coding of the information by varying the stimulation rate. The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch (of normal-hearing) and less variability, especially at low frequencies. With fixed stimulation rate (classical strategy) low frequencies are poorly coded, whereas with the variable stimulation rate they are better coded. In addition, Landsberger et al. [2018] studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion: middle or apical position. The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding (related to the position of the electrode) at the apex, and the reverse on the electrodes in the middle position. Studies have shown that the FineHearing strategy can provide benefits over the classic HDCIS strategy in tasks involving the fundamental F0 such as speech recognition in noise (after a certain learning time) [Kleine Punte & al. 2014 ; Vermeire & al. 2010], the perception of music [Roy & al. 2015 ; Roy & al. 2016] or the perceived quality of pitch [Müller & al. 2012]. The results obtained seem to depend on the position of the electrode: a deep insertion to reach the apical zone of the cochlea would allow better coding of the information. MED-EL's FineHearing coding strategy with stimulation of the apical areas of the cochlea (long insertion of electrodes) could therefore allow better transmission of musical pitch and in particular improve the subjective quality of music compared to the same stimulation strategy without reaching the apical areas (short insertion). Objective of the study: The objective of the study is to evaluate if the FineHearing strategy of MED-EL with stimulation of the apical zones allows to better transmit musical pitch and in particular to improve the subjective quality of the music compared to the same stimulation strategy without apical stimulation. Main objective: Show that the FineHearing strategy of MED-EL with stimulation of the apical zones allows to obtain a better perceptual quality of music in newly implanted cochlear patients than the same strategy without apical stimulation. Secondary objectives: Evaluate differential frequency thresholds and correlation with qualitative perceptions of music. Evaluate the effect of the stimulation of the apical zones on the results of speech audiometry with the FineHearing strategy. Evaluate the effect of the stimulation of the apical zones on the subjective quality of sounds by questionnaire with the FineHearing strategy. Plan of study: it is a Single-center, randomized, double-blind, cross-over study

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
Crossover Assignment two arms A and B: Arm A: patient's fitting with strategy FS4 and 10 more apical electrodes activated--> 1 month use --> tests and patient's fitting with strategy FS4 and 10 more basal electrodes --> 1 month use --> tests Arm B: patient's fitting with strategy FS4 and 10 more basal electrodes activated --> 1 month use --> tests and patient's fitting with strategy FS4 and 10 more apical electrodes --> 1 month use --> tests
Masking
ParticipantInvestigator
Masking Description
Double blind study: the patient and the investigator don't know the strategy
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated
Arm Type
Active Comparator
Arm Description
Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month
Arm Title
CI with FineHearing with 10 more basal electrodes activated then 10 more apical electrodes activated
Arm Type
Active Comparator
Arm Description
Cochlear implant with FineHearing Strategy with 10 more basal electrodes activated first during 1 month then FineHearing Strategy with 10 more apical electrodes activated during 1 month
Intervention Type
Device
Intervention Name(s)
FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
Intervention Description
Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated
Primary Outcome Measure Information:
Title
Qualitative measure of music with direct audio link
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). The test is performed with a direct audio link to the CI.
Time Frame
at 1 month post-activation
Title
Qualitative measure of music with direct audio link
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). The test is performed with a direct audio link to the CI.
Time Frame
at 2 months post-activation
Secondary 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). The test is performed in free field without any contralateral aid.
Time Frame
at 1 month 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 (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed in free field without any contralateral aid.
Time Frame
at 2 months post-activation
Title
Speech recognition in quiet
Description
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Time Frame
at 1 month post-activation
Title
Speech recognition in quiet
Description
The speech recognition in quiet is evaluated with 3 monosyllabic list of 17 words at 60 dB SPL. The patient has to recognize 17 words and 51 phonemes. The words and phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 for the words and the phonemes (or 0% and 100%).
Time Frame
at 2 months 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 1 month 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 2 months post-activation
Title
Sound quality
Description
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.
Time Frame
at 1 month post-activation
Title
Sound quality
Description
The HISQUI questionnaire will be used to evaluate the sound quality. The HISQUI questionnaire (Hearing Implant Sound Quality Index) is a questionnaire on the perceptual quality of sounds given a score (maximum=203) for each patient which indicates how he/she perceives the sound quality with his/her hearing implant in the everyday life.
Time Frame
at 2 months 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 Patient with a postoperative insertion angle of the apical electrode > 450° Patient with 12 active electrodes on the day of activation. Exclusion Criteria: Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Péan, PhD
Phone
(+33) 603592974
Email
vincent.pean@medel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Mosnier, Dr
Organizational Affiliation
Service ORL, UF Implants auditifs et explorations fonctionnelles GH Pitié-Salpêtrière, APHP 6 Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
GH Pitié-Salpêtrière, APHP 6
City
Paris
ZIP/Postal Code
75651 Paris Cedex 13
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Mosnier, Dr
Phone
(+33) 1 42 16 26 06
Email
isabelle.mosnier@aphp.fr

12. IPD Sharing Statement

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Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

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