Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754918
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-02-22
Brief Title:
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
Comparison of Speech Understanding and Melodic Perception of Two Tonotopic Fitting Modalities With or Without Fine Structure in Newly Implanted Cochlear Patients Randomized Double-blind Crossover Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief Summary
Main objective
Comparison of a tonotopy based fitting strategy TFS with fine structure coding to a tonotopy based fitting strategy without fine structure coding TnoFS for speech perception in noise
Secondary objectives
Comparison of TFS to TnoFS for the perception of musical elements contour test
Comparison of TFS to TnoFS for speech perception in quiet
Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces
Comparison of TFS to TnoFS for the melodic recognition
Main objective
Comparison of a tonotopy based fitting strategy TFS with fine structure coding to a tonotopy based fitting strategy without fine structure coding TnoFS for speech perception in noise
Secondary objectives
Comparison of TFS to TnoFS for the perception of musical elements contour test
Comparison of TFS to TnoFS for speech perception in quiet
Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces
Comparison of TFS to TnoFS for the melodic recognition
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 Nimmons et al
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
Conventional stimulation strategies in cochlear implants eg advanced combination encoder ACE continuous interleaved sampling CIS use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes The stimulation rate of the electrodes is constant The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music In the FineHearing strategy of the MED-EL implant the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally
Rader al 2016 have studied the contribution of adding to the tonotopic coding of the frequency classical strategy a temporal coding of the information by varying the stimulation rate The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch of normal-hearing and less variability especially at low frequencies With fixed stimulation rate classical strategy low frequencies are poorly coded whereas with the variable stimulation rate they are better coded In addition Landsberger et al 2018 studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion middle or apical position The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding related to the position of the electrode at the apex and the reverse on the electrodes in the middle position Studies have shown that the FineHearing strategy can provide benefits over the classic High-Definition Continuous Interleaved Sampling HDCIS strategy in tasks involving the fundamental F0 such as speech recognition in noise after a certain learning time Kleine Punte al 2014 Vermeire al 2010 the perception of music Roy al 2015 Roy al 2016 or the perceived quality of pitch Müller al 2012
MED-ELs FineHearing coding strategy with a tonotopic-based fitting could therefore allow better transmission of pitch and in particular improve the speech recognition in noise compared to the same tonotopic-based fitting without FineHearing coding
Main objective
Comparison of a tonotopy based fitting strategy TFS with fine structure coding to a tonotopy based fitting strategy without fine structure coding TnoFS for speech perception in noise
Secondary objectives
Comparison of TFS to TnoFS for the perception of musical elements contour test
Comparison of TFS to TnoFS for speech perception in quiet
Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces
Comparison of TFS to TnoFS for the melodic recognition
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
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
Conventional stimulation strategies in cochlear implants eg advanced combination encoder ACE continuous interleaved sampling CIS use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes The stimulation rate of the electrodes is constant The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music In the FineHearing strategy of the MED-EL implant the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally
Rader al 2016 have studied the contribution of adding to the tonotopic coding of the frequency classical strategy a temporal coding of the information by varying the stimulation rate The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch of normal-hearing and less variability especially at low frequencies With fixed stimulation rate classical strategy low frequencies are poorly coded whereas with the variable stimulation rate they are better coded In addition Landsberger et al 2018 studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion middle or apical position The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding related to the position of the electrode at the apex and the reverse on the electrodes in the middle position Studies have shown that the FineHearing strategy can provide benefits over the classic High-Definition Continuous Interleaved Sampling HDCIS strategy in tasks involving the fundamental F0 such as speech recognition in noise after a certain learning time Kleine Punte al 2014 Vermeire al 2010 the perception of music Roy al 2015 Roy al 2016 or the perceived quality of pitch Müller al 2012
MED-ELs FineHearing coding strategy with a tonotopic-based fitting could therefore allow better transmission of pitch and in particular improve the speech recognition in noise compared to the same tonotopic-based fitting without FineHearing coding
Main objective
Comparison of a tonotopy based fitting strategy TFS with fine structure coding to a tonotopy based fitting strategy without fine structure coding TnoFS for speech perception in noise
Secondary objectives
Comparison of TFS to TnoFS for the perception of musical elements contour test
Comparison of TFS to TnoFS for speech perception in quiet
Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces
Comparison of TFS to TnoFS for the melodic recognition
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None