Sensorineural Hearing Loss, BilateralNCT03993899
Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
A study testing FineHearing strategy or HDCIS strategy 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 Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces. 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?
- FineHearing strategy or HDCIS strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 7 Jan 2020
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Coding the Fine Structure of the Sound on the Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.
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.
Read more
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
Read the detailed description
Introduction:
At present, most people with modern cochlear implant systems can understand speech using the device alone, at least under favorable listening conditions.
In recent years, research has increasing focussed on how implant users perceive sounds other than speech. In particular, music perception is of interest.
A review of the literature on musical perception with traditional implants, coding only the temporal envelope [McDermott 2004], revealed the following elements:
- On average, implant users perceive the rhythm approximately as well as listeners with normal hearing
- With technically sophisticated multi-channel sound processors, melody recognition, especially without rhythmic or verbal cues, is poor.
- The perception of timbre, especially the sounds of musical instruments, is generally unsatisfactory.
- Implant users tend to rate the quality of musical sounds as less enjoyable than listeners with normal hearing And studies show that the fine structure of sound is the main vector of information for music and the location of sounds. [Smith et al. 2002] It therefore seems necessary to focus on the contribution of the coding of the fine temporal structure of sound to the cochlear implant.
Main objective:
Show the superiority of FS4 strategy compared to 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
Plan of the study:
It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 15 days and 30 days post-activation.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- FineHearing strategy or HDCIS strategy
- Keywords
- cochlear implant stimulation strategy sound coding strategy
- 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.
FineHearing strategy or HDCIS strategyDevice
Cochlear implant with FineHearing strategy or HDCIS strategy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: FineHearing strategy or HDCIS strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: at 30 days 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 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 15 days post-activation
Speech recognition in quiet
The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 21 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).
Measured: at 30 days post-activation
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Measured: at 15 days post-activation
Differential frequency threshold
This test aimed to determine the smallest perceptible difference in F0 between two stimuli for various baseline values of F0. An adaptive procedure is used.
Measured: at 30 days 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 corresponded 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 15 days 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 corresponded 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 30 days post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Jul 2019
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- 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 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT03993899
- Sponsor's protocol ID
- MED_EL_FS_music_Rennes_study
- Status last verified
- Jan 2020
- First submitted
- 19 Jun 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Coding the Fine Structure of the Sound on the Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.
- ClinicalTrials.gov ID
- NCT03993899
- Acronym / sponsor ID
- MED_EL_FS_music_Rennes_study
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- cochlear implant stimulation strategy sound coding strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 21 Jun 2019 (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 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
Detailed description
Introduction:
At present, most people with modern cochlear implant systems can understand speech using the device alone, at least under favorable listening conditions.
In recent years, research has increasing focussed on how implant users perceive sounds other than speech. In particular, music perception is of interest.
A review of the literature on musical perception with traditional implants, coding only the temporal envelope [McDermott 2004], revealed the following elements:
- On average, implant users perceive the rhythm approximately as well as listeners with normal hearing
- With technically sophisticated multi-channel sound processors, melody recognition, especially without rhythmic or verbal cues, is poor.
- The perception of timbre, especially the sounds of musical instruments, is generally unsatisfactory.
- Implant users tend to rate the quality of musical sounds as less enjoyable than listeners with normal hearing And studies show that the fine structure of sound is the main vector of information for music and the location of sounds. [Smith et al. 2002] It therefore seems necessary to focus on the contribution of the coding of the fine temporal structure of sound to the cochlear implant.
Main objective:
Show the superiority of FS4 strategy compared to 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
Plan of the study:
It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 15 days and 30 days 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 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
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant (CI) with FineHearing Strategy then HDCIS | Active comparator | Device: FineHearing strategy or HDCIS strategycochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days |
| CI with HDCIS Strategy then FS4 | Active comparator | Device: FineHearing strategy or HDCIS strategycochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days |
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 (1 listed)
- Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
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 |
|---|---|---|
| FineHearing strategy or HDCIS strategyCochlear implant with FineHearing strategy or HDCIS strategy | Device | CI with HDCIS Strategy then FS4, Cochlear implant (CI) with FineHearing Strategy then HDCIS |
Primary outcome
Qualitative measure of music
Time frame: at 15 days post-activation
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).
Qualitative measure of music
Time frame: at 30 days post-activation
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).
6 secondary outcomes
Speech recognition in quiet
Time frame: at 15 days post-activation
Speech recognition in quiet
Time frame: at 30 days post-activation
Differential frequency threshold
Time frame: at 15 days post-activation
Differential frequency threshold
Time frame: at 30 days post-activation
Melodic contour test
Time frame: at 15 days post-activation
Melodic contour test
Time frame: at 30 days 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 9 Jan 2020.
- 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 FineHearing strategy or HDCIS strategy 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 1 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 9 Jan 2020. 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?
Qualitative measure of music (time frame: at 15 days 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?
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 9 Jan 2020.