Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694704
Recruitment Status : Suspended (COVID-19)
First Posted : October 3, 2018
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
MED-EL Elektromedizinische Geräte GesmbH

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

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694704


Locations
Layout table for location information
France
CHU Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
MED-EL Elektromedizinische Geräte GesmbH
Investigators
Layout table for investigator information
Principal Investigator: Mathieu Marx, Pr University Hospital, Toulouse
Layout table for additonal 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    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases