Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy

January 7, 2020 updated by: MED-EL Elektromedizinische Geräte GesmbH

Evaluation of the Impact of Coding the Fine Structure of the Sound on the Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

Main objective:

Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.

Secondary objectives

  • Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test).
  • Analyze the link between the results of musical perception tests and the subjective preference of musical listening.
  • Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements.
  • Analyze the link between the results of musical perception tests and the results of the perception of speech elements.
  • Analyze the qualitative multidimensional perception with HDCIS and FS4

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction:

At present, most people with modern cochlear implant systems can understand speech using the device alone, at least under favorable listening conditions.

In recent years, research has increasing focussed on how implant users perceive sounds other than speech. In particular, music perception is of interest.

A review of the literature on musical perception with traditional implants, coding only the temporal envelope [McDermott 2004], revealed the following elements:

  • On average, implant users perceive the rhythm approximately as well as listeners with normal hearing
  • With technically sophisticated multi-channel sound processors, melody recognition, especially without rhythmic or verbal cues, is poor.
  • The perception of timbre, especially the sounds of musical instruments, is generally unsatisfactory.
  • Implant users tend to rate the quality of musical sounds as less enjoyable than listeners with normal hearing And studies show that the fine structure of sound is the main vector of information for music and the location of sounds. [Smith et al. 2002] It therefore seems necessary to focus on the contribution of the coding of the fine temporal structure of sound to the cochlear implant.

Main objective:

Show the superiority of FS4 strategy compared to HDCIS strategy on the qualitative preference for the listening of musical pieces.

Secondary objectives:

  • Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test).
  • Analyze the link between the results of musical perception tests and the subjective preference of musical listening.
  • Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements.
  • Analyze the link between the results of musical perception tests and the results of the perception of speech elements.
  • Analyze the qualitative multidimensional perception with HDCIS and FS4

Plan of the study:

It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 15 days and 30 days post-activation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Chu Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Cochlear implant (CI) with FineHearing Strategy then HDCIS
cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days
Device: FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
ACTIVE_COMPARATOR: CI with HDCIS Strategy then FS4
cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days
Device: FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qualitative measure of music
Time Frame: at 15 days post-activation
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).
at 15 days post-activation
Qualitative measure of music
Time Frame: at 30 days post-activation
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 are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10).
at 30 days post-activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speech recognition in quiet
Time Frame: at 15 days post-activation
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 15 days post-activation
Speech recognition in quiet
Time Frame: at 30 days post-activation
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 30 days post-activation
Differential frequency threshold
Time Frame: at 15 days 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.
at 15 days post-activation
Differential frequency threshold
Time Frame: at 30 days 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.
at 30 days post-activation
Melodic contour test
Time Frame: at 15 days post-activation
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded 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%).
at 15 days post-activation
Melodic contour test
Time Frame: at 30 days post-activation
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies corresponded 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%).
at 30 days post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MED-EL Elektromedizinische Geräte GesmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MED_EL_FS_music_Rennes_study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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