Sensorineural Hearing Loss, BilateralNCT04922619
Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting
A study testing tonotopy based fitting then default fitting and default fitting then tonotopy based fitting in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- tonotopy based fitting then default fitting and default fitting then tonotopy based fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Who cannot join
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Tonotopy Based Fitting on the Speech and Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.
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.
Read the 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.
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
- Sensorineural Hearing Loss, Bilateral
- Being tested
- tonotopy based fitting then default fitting, default fitting then tonotopy based fitting
- Keywords
- cochlear implant strategy, tonotopy based fitting
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonotopy based fitting then default fittingDevice
Cochlear implant with default fitting then tonotopy based fitting
default fitting then tonotopy based fittingDevice
Cochlear implant with tonotopy based fitting then default fitting
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant (CI) with default fitting then tonotopy based fitting | Active comparator | Cochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks Receives: Device: tonotopy based fitting then default fitting; Device: default fitting then tonotopy based fitting |
| Cochlear Implant (CI) with tonotopy based fitting then default fitting | Active comparator | Cochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks Receives: Device: tonotopy based fitting then default fitting; Device: default fitting then tonotopy based fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
speech recognition in noise
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
Measured: at 6 weeks post-activation
speech recognition in noise
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
Measured: at 12 weeks post-activation
Secondary outcomes (6)
speech recognition in quiet
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 6 weeks post-activation
speech recognition in quiet
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 12 weeks post-activation
Melodic contour test
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies correspond to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 6 weeks post-activation
Melodic contour test
The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies correspond to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 12 weeks 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 sound, 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).
Measured: at 6 weeks 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 sound, 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).
Measured: at 12 weeks post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 Jun 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two arms A and B: 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benoit Godey, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922619
- Sponsor's protocol ID
- MED_EL_tonofit_Rennes_study
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39264640
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Tonotopy Based Fitting on the Speech and Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.
- ClinicalTrials.gov ID
- NCT04922619
- Acronym / sponsor ID
- MED_EL_tonofit_Rennes_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant strategy, tonotopy based fitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two arms A and B: 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
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant (CI) with default fitting then tonotopy based fitting | Active comparator | Device: tonotopy based fitting then default fitting, Device: default fitting then tonotopy based fittingCochlear Implant with default fitting first during 6 weeks then with tonotopy based fitting during 6 weeks |
| Cochlear Implant (CI) with tonotopy based fitting then default fitting | Active comparator | Device: tonotopy based fitting then default fitting, Device: default fitting then tonotopy based fittingCochlear Implant with tonotopy based fitting during 6 weeks then with default fitting during 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Key exclusion criteria (2 listed)
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tonotopy based fitting then default fittingCochlear implant with default fitting then tonotopy based fitting | Device | Cochlear Implant (CI) with default fitting then tonotopy based fitting, Cochlear Implant (CI) with tonotopy based fitting then default fitting |
| default fitting then tonotopy based fittingCochlear implant with tonotopy based fitting then default fitting | Device | Cochlear Implant (CI) with default fitting then tonotopy based fitting, Cochlear Implant (CI) with tonotopy based fitting then default fitting |
Primary outcome
speech recognition in noise
Time frame: at 6 weeks post-activation
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
speech recognition in noise
Time frame: at 12 weeks post-activation
The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.
6 secondary outcomes
speech recognition in quiet
Time frame: at 6 weeks post-activation
speech recognition in quiet
Time frame: at 12 weeks post-activation
Melodic contour test
Time frame: at 6 weeks post-activation
Melodic contour test
Time frame: at 12 weeks post-activation
Qualitative measure of music
Time frame: at 6 weeks post-activation
Qualitative measure of music
Time frame: at 12 weeks post-activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 39264640Creff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Godey, Pr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tonotopy based fitting then default fitting and default fitting then tonotopy based fitting in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
speech recognition in noise (time frame: at 6 weeks post-activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.