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出境医 / 临床实验 / Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Study Description
Brief 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.
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sensorineural Hearing Loss, Bilateral | Device: FineHearing strategy or HDCIS strategy | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention 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 (Participant, Investigator) |
| Masking Description: | Double blind study: the patient and the investigator don't know the strategy |
| Primary Purpose: | Other |
| 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. |
| Actual Study Start Date : | July 1, 2019 |
| Actual Primary Completion Date : | January 7, 2020 |
| Actual Study Completion Date : | January 7, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Cochlear implant (CI) with FineHearing Strategy then HDCIS
cochlear implant with FineHearing strategy first during 15 days then with HDCIS strategy during 15 days
|
Device: FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
|
|
Active Comparator: CI with HDCIS Strategy then FS4
cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days
|
Device: FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
|
Outcome Measures
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- Speech recognition in quiet [ Time Frame: at 15 days post-activation ]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%).
- Speech recognition in quiet [ Time Frame: at 30 days post-activation ]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%).
- Differential frequency threshold [ Time Frame: at 15 days post-activation ]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.
- Differential frequency threshold [ Time Frame: at 30 days post-activation ]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.
- Melodic contour test [ Time Frame: at 15 days post-activation ]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%).
- Melodic contour test [ Time Frame: at 30 days post-activation ]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%).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| France | |
| CHU Rennes | |
| Rennes, France, 35000 | |
Sponsors and Collaborators
MED-EL Elektromedizinische Geräte GesmbH
Investigators
| Principal Investigator: | Benoit Godey, Pr | Rennes University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 19, 2019 | ||||
| First Posted Date ICMJE | June 21, 2019 | ||||
| Last Update Posted Date | January 9, 2020 | ||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||
| Actual Primary Completion Date | January 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy | ||||
| Official Title ICMJE | 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. | ||||
| Brief 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. Secondary objectives
|
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| 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:
Main objective: Show the superiority of FS4 strategy compared to HDCIS strategy on the qualitative preference for the listening of musical pieces. Secondary objectives:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention 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 Description: Double blind study: the patient and the investigator don't know the strategy Primary Purpose: Other
|
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| Condition ICMJE | Sensorineural Hearing Loss, Bilateral | ||||
| Intervention ICMJE | Device: FineHearing strategy or HDCIS strategy
Cochlear implant with FineHearing strategy or HDCIS strategy
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
19 | ||||
| Original Estimated Enrollment ICMJE |
18 | ||||
| Actual Study Completion Date ICMJE | January 7, 2020 | ||||
| Actual Primary Completion Date | January 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: - Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03993899 | ||||
| Other Study ID Numbers ICMJE | MED_EL_FS_music_Rennes_study | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | MED-EL Elektromedizinische Geräte GesmbH | ||||
| Study Sponsor ICMJE | MED-EL Elektromedizinische Geräte GesmbH | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | MED-EL Elektromedizinische Geräte GesmbH | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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