Clinical trial NCT03993899: Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Keywords: cochlear implant stimulation strategy sound coding strategy
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2019-06-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two arms A and B:

Arm A: patient's fitting with strategy FS4 --\> 15 days use --\> tests and patient's fitting with strategy HDCIS --\> 15 days use --\> tests

Arm B: patient's fitting with strategy HDCIS --\> 15 days use --\> tests and patient's fitting with strategy FS4 --\> 15 days use --\> tests
Primary purpose: OTHER

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative measure of music
timeFrame: at 15 days post-activation
measure: Qualitative measure of music
timeFrame: at 30 days post-activation
Secondary outcomes:
measure: Speech recognition in quiet
timeFrame: at 15 days post-activation
measure: Speech recognition in quiet
timeFrame: at 30 days post-activation
measure: Differential frequency threshold
timeFrame: at 15 days post-activation
measure: Differential frequency threshold
timeFrame: at 30 days post-activation
measure: Melodic contour test
timeFrame: at 15 days post-activation
measure: Melodic contour test
timeFrame: at 30 days post-activation
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Benoit Godey, Pr
role: PRINCIPAL_INVESTIGATOR
References: