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

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: Completed
• Conditions: Sensorineural Hearing Loss, Bilateral
• Intervention / Treatment: Device: FineHearing strategy or HDCIS strategy

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: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	at 15 days post-activation
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 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

Outcome Measure	Measure Description	Time Frame
Speech recognition in quiet	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	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	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	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	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	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

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): January 7, 2020
• Study Completion (ACTUAL): January 7, 2020

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: cochlear implant stimulation strategy sound coding strategy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID 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