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

• ClinicalTrials.gov Identifier: NCT03694704
• Recruitment Status: Suspended
• First Posted: October 3, 2018
• Last Update Posted: April 27, 2021
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Information provided by (Responsible Party): MED-EL Elektromedizinische Geräte GesmbH

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

Condition or disease	Intervention/treatment	Phase
Sensorineural Hearing Loss, Bilateral	Device: FineHearing strategy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: February 28, 2019
• Estimated Primary Completion Date: April 28, 2022
• Estimated Study Completion Date: April 28, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: CI with FineHearing Strategy; cochlear implant with FineHearing strategy	Device: FineHearing strategy; Cochlear implant with FineHearing strategy

Outcome Measures

Primary Outcome Measures :

1. Prosodic test [ Time Frame: at 12 month post-activation ]
   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 :

1. Differential frequency threshold [ Time Frame: at 6 month post-activation ]
   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.
2. Prosodic test [ Time Frame: at 6 month post-activation ]
   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
3. Vocal audiometry in quiet and noise [ Time Frame: at 6 month post-activation ]

   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.

4. Differential frequency threshold [ Time Frame: at 12 month post-activation ]
   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.
5. Vocal audiometry in quiet and noise [ Time Frame: at 12 month post-activation ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

CHU Toulouse

Toulouse, France, 31000

Sponsors and Collaborators

MED-EL Elektromedizinische Geräte GesmbH

Investigators

• Principal Investigator: Mathieu Marx, Pr; University Hospital, Toulouse

More Information

• Responsible Party: MED-EL Elektromedizinische Geräte GesmbH
• ClinicalTrials.gov Identifier: NCT03694704
• Other Study ID Numbers: MED-EL_FS_prosody_french_study
• First Posted: October 3, 2018
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by MED-EL Elektromedizinische Geräte GesmbH:

cochlear implant; stimulation strategy; sound coding strategy

Additional relevant MeSH terms:

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases