Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting
NCT ID: NCT04922619
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-06-10
2021-09-30
Brief Summary
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Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.
Secondary objectives:
Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test).
Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet.
Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.
Detailed Description
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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 (Stakhovskaya O et al., P. Pelliccia et al.).
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 (Deep electrode insertion and sound coding in cochlear implants - Ingeborg Hochmair et al.).
Mathematical algorithms have recently been developed to estimate the cochlear tonotopy of each patient from a CT scan assessment (Jiam et al., Sridhar et al.). CT imaging of the implanted ear combined with 3D reconstruction software, provides cochlear length measurements (Cochlear length determination using Cone Beam Computed Tomography in a clinical setting - Würfel et al .) Using this approach it is possible to measure the position of each electrode relative to the cochlear apex. These measurements are applied to the modified Greenwood equation to obtain the tonotopic frequency for each electrode and to determine for each patient a fitting based on the tonotopy of each electrode.
Main objective:
Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.
Secondary objectives:
Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test).
Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet.
Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.
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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Arm A: patient's fitting with default fitting --\> 6 weeks use --\> tests and patient's fitting with tonotopy based fitting --\> 6 weeks use --\> tests
Arm B: patient's fitting with tonotopy based fitting --\> 6 weeks use --\> tests and patient's fitting with default fitting --\> 6 weeks use --\> tests
OTHER
DOUBLE
Study Groups
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Cochlear Implant (CI) with default fitting then tonotopy based fitting
Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks
tonotopy based fitting then default fitting
Cochlear implant with default fitting then tonotopy based fitting
default fitting then tonotopy based fitting
Cochlear implant with tonotopy based fitting then default fitting
Cochlear Implant (CI) with tonotopy based fitting then default fitting
Cochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks
tonotopy based fitting then default fitting
Cochlear implant with default fitting then tonotopy based fitting
default fitting then tonotopy based fitting
Cochlear implant with tonotopy based fitting then default fitting
Interventions
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tonotopy based fitting then default fitting
Cochlear implant with default fitting then tonotopy based fitting
default fitting then tonotopy based fitting
Cochlear implant with tonotopy based fitting then default fitting
Eligibility Criteria
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Inclusion Criteria
* Patient who fulfils the criteria for cochlear implantation
Exclusion Criteria
* patient with residual hearing \< 60 dB HL at 250 Hz and \< 80 dB HL at 500 Hz
18 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Benoit Godey, Pr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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CHU Rennes
Rennes, , France
Countries
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References
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Creff G, Bernard-Le Liboux N, Coudert P, Bourdon H, Pean V, Wallaert N, Lambert C, Godey B. Tonotopic and Default Frequency Fitting for Music Perception in Cochlear Implant Recipients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):960-968. doi: 10.1001/jamaoto.2024.2895.
Other Identifiers
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MED_EL_tonofit_Rennes_study
Identifier Type: -
Identifier Source: org_study_id