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Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

Primary Purpose

Sensorineural Hearing Loss, Bilateral

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FineHearing strategy
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:

  • Patient with MED-EL cochlear implant (Sonnet / Synchrony)
  • Adult patient (≥ 18 years old) speaking French
  • Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation.
  • Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)
  • Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-activation

Exclusion criteria:

  • Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CI with FineHearing Strategy

Arm Description

cochlear implant with FineHearing strategy

Outcomes

Primary Outcome Measures

Prosodic test
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24

Secondary Outcome Measures

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.
Prosodic test
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
Vocal audiometry in quiet and noise
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.
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.
Vocal audiometry in quiet and noise
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.

Full Information

First Posted
September 26, 2018
Last Updated
May 4, 2022
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03694704
Brief Title
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
Official Title
Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
April 28, 2022 (Anticipated)
Study Completion Date
April 28, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results
Detailed Description
Introduction: Prosodie is the study of the phenomena of accentuation and intonation (variation of pitch, duration and intensity) allowing the conveyance of information related to the sense such as the relief, but also the assertion, interrogation, injunction, exclamation ... It has a role at the grammatical, emotional and pragmatic levels of communication by informing about the emotional state of the speaker (sad / happy), about sex and identity, about the type of statement (question / affirmation) and about the borders in the sentences. The auditory cues that play a role in the perception of prosody include changes in the fundamental frequency F0 (ie vibrational frequency of the speaker's vocal cords) during a speech, the duration of the syllables, or the rate or intensity of the speech. [Di Christo 2013] The cochlear implant is a device for auditory rehabilitation. Its principle is to transform the analog signals recorded by a microphone into digital signals that directly stimulate the fibers of the auditory nerve through electrodes inserted into the cochlea. [HAS 2012, HAS 2007, http://www.has-sante.fr] Cochlear implants are indicated in cases of severe or profound sensorineural deafness. 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. [Wilson & Dorman 2008] The pitch is only partially transmitted by these conventional strategies [Moore 2003; Oxenham 2008] which would explain the poor results of cochlear implants in the perception of music [Bruns & al. 2016; Galvin III & al. 2009; Veekmans & al. 2009; Cooper & al. 2008] and prosody [Kalathottukaren & al. 2015 ; Meister et al. 2011; Meister et al. 2009]. 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. The FineHearing coding strategy of MED-EL with long insertion of electrode could therefore make it possible to better transmit the prosody and specifically to better extract the fundamental frequency F0 of the voice. Objective of the study The objective of the study is to evaluate if the FineHearing strategy of the MED-EL implant allows to better transmit the prosody and specifically by the fundamental frequency of the voice (F0). Main objective: Show that the MED-EL FineHearing strategy (with deep insertion of the electrode) allows to extract prosody cues based only on the fundamental frequency F0. Secondary objectives: evaluate differential frequency thresholds and correlation with prosodic performance Evaluate the positioning of the electrode array and its effect on prosodic performance Plan of study: It is a prospective open multicenter longitudinal study: measures will be done on the patient at 6 and 12 month 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI with FineHearing Strategy
Arm Type
Experimental
Arm Description
cochlear implant with FineHearing strategy
Intervention Type
Device
Intervention Name(s)
FineHearing strategy
Intervention Description
Cochlear implant with FineHearing strategy
Primary Outcome Measure Information:
Title
Prosodic test
Description
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
Time Frame
at 12 month post-activation
Secondary Outcome Measure Information:
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 6 month post-activation
Title
Prosodic test
Description
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
Time Frame
at 6 month post-activation
Title
Vocal audiometry in quiet and noise
Description
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.
Time Frame
at 6 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 12 month post-activation
Title
Vocal audiometry in quiet and noise
Description
Word recognition test in quiet with 10 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal to noise ratio (SRT50) to have 50% of sentence recognition in noise. Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) of comprehension of sentences free field with the cochlear implant.
Time Frame
at 12 month post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with MED-EL cochlear implant (Sonnet / Synchrony) Adult patient (≥ 18 years old) speaking French Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation. Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing) Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-activation Exclusion criteria: Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Marx, Pr
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

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