Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting

February 23, 2024 updated by: MED-EL Elektromedizinische Geräte GesmbH

Comparison of an Anatomy-based Fitting and a Conventional Fitting in Newly Implanted Cochlear Patients. Prospective Monocentric Randomized Double-blind Crossover Study.

Main objective:

Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.

Secondary objectives:

Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain. A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist. The fitting software developed by the manufacturers proposed a default fitting with a lower limit between 100 and 250 Hz according to the brands and an upper limit of about 8500 Hz. The frequency bands assigned to each electrode follow a logarithmic scale with the high frequencies for the basal electrodes and the low frequencies for the apical electrodes. This distribution takes into account the number of active electrodes but does not take into account the anatomy and the natural cochlear tonotopy specific to each patient. Several studies have analyzed the anatomical variations of the cochlear dimensions: size of the cochlea and the ratio between the contact surfaces of the electrodes with the cochlea are variable from one patient to another. The insertion depth during surgery is also variable due to parameters related to the patients as well as to the operator, which seems to impact the understanding of speech in noise. Mathematical algorithms have recently been developed to estimate the cochlear tonotopy of each patient from a CT scan assessment. CT imaging of the implanted ear combined with 3D reconstruction software, provides cochlear length measurements Using this approach it is possible to measure the position of each electrode relative to the cochlear apex. Recently, MED-EL (Austria) has developed a new approach based on CT-scan and tuning of the frequencies associated with each electrode using anatomical information of position of the electrodes in the cochlea: this fitting is called anatomy-based fitting.

Main objective:

Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.

Secondary objectives:

Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Plan of the study:

It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 6 weeks and 12 weeks post-activation.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • 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 Contact

Study Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cochlear Implant (CI) with default fitting then anatomy-based fitting
Cochlear Implant with default fitting first during 6 weeks then with anatomy-based fitting during 6 weeks
Device: default fitting then anatomy-based fitting
Cochlear implant with anatomy-based fitting then default fitting
Active Comparator: Cochlear Implant (CI) with anatomy-based fitting then default fitting
Cochlear Implant with anatomy-based fitting during 6 weeks then with default fitting during 6 weeks
Device: anatomy-based fitting then default fitting
Cochlear implant with anatomy-based fitting then default fitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recognition of Environmental sounds
Time Frame: at 6 weeks post-activation
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 6 weeks post-activation
Recognition of Environmental sounds
Time Frame: at 12 weeks post-activation
The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 12 weeks post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition in quiet
Time Frame: at 6 weeks post-activation
The speech recognition in quiet is evaluated with 3 lists of 10 disyllabic words. The patient has to recognize 30 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 6 weeks post-activation
Speech recognition in quiet
Time Frame: at 12 weeks post-activation
The speech recognition in quiet is evaluated with 3 lists of 10 disyllabic words. The patient has to recognize 30 words. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
at 12 weeks post-activation
Speech recognition in noise
Time Frame: at 6 weeks post-activation
The speech recognition in noise is evaluated with the French-language "Rapid speech in noise" (VRB) test (Leclerc et al. 2018). The speech level is at 65 dB SPL. The patient has to recognize 3 target words by sentence. The 8 sentences are played with signal-to-noise ratios between +18 dB and -3 dB by steps of 3 dB. The SRT50 (threshold for 50% intelligibility in noise) is obtained by SRT50 = 19,5 - R, with R = number of correct answers (on 24).
at 6 weeks post-activation
Speech recognition in noise
Time Frame: at 12 weeks post-activation
The speech recognition in noise is evaluated with the French-language VRB test (Leclerc et al. 2018). The speech level is at 65 dB SPL. The patient has to recognize 3 target words by sentence. The 8 sentences are played with signal-to-noise ratios between +18 dB and -3 dB by steps of 3 dB. The SRT50 (threshold for 50% intelligibility in noise) is obtained by SRT50 = 19,5 - R, with R=number of correct answers (on 24).
at 12 weeks post-activation

Collaborators and Investigators

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

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Investigators

  • Principal Investigator: Damien Bonnard, Dr, University Hospital, Bordeaux

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)

February 15, 2022

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDEL_anatfit_Bordeaux_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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