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

NCT03993899 | Completed

• 1 other identifier: MED_EL_FS_music_Rennes_study
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant stimulation strategy sound coding strategy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Speech recognition in quiet

  at 15 days post-activation

• Speech recognition in quiet

  at 30 days post-activation

• Differential frequency threshold

  at 15 days post-activation

• Differential frequency threshold

  at 30 days post-activation

• Melodic contour test

  at 15 days post-activation

Study Arms (2)

Cochlear implant (CI) with FineHearing Strategy then HDCIS

ACTIVE COMPARATOR

cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days

Device: FineHearing strategy or HDCIS strategy

CI with HDCIS Strategy then FS4

ACTIVE COMPARATOR

cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days

Device: FineHearing strategy or HDCIS strategy

Interventions

FineHearing strategy or HDCIS strategy DEVICE

Cochlear implant with FineHearing strategy or HDCIS strategy

CI with HDCIS Strategy then FS4; Cochlear implant (CI) with FineHearing Strategy then HDCIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥ 18 years old) speaking French
• Patient who fulfils the criteria for cochlear implantation

You may not qualify if:

• \- Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benoit Godey, Pr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study: the patient and the investigator don't know the strategy
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: July 1, 2019
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)