Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| CI with HDCIS Strategy then FS4 | Active Comparator | cochlear implant with HDCIS strategy first during 15 days then with FS4 strategy during 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FineHearing strategy or HDCIS strategy | Device | Cochlear implant with FineHearing strategy or HDCIS strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | at 30 days post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | at 15 days post-activation |
| Speech recognition in quiet |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benoit Godey, Pr | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Rennes | 35000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
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
Not provided
Not provided
Double blind study: the patient and the investigator don't know the strategy
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%). |
| 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. | 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. | 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%). | 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%). | at 30 days post-activation |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |