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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.
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| Measure | Description | Time Frame |
|---|---|---|
| Score of the French MBAA2 Sentence Recognition Test in Quiet | Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of <90/100 correct sentence. | 1 month post activation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.
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| Name | Affiliation | Role |
|---|---|---|
| Mathieu Marx, MD | Hôpital Pierre-Paul Riquet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique | Toulouse | 31059 | France |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request
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32 participants were recruited between 21 April 2022 and 24 August 2022. The aim was to recruit 30 participants with data for the primary endpoint. As it was noted during the data collection period that data was missing, the number was increased to 32.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults Using Currently a Nucleus Cochlear Implant | Adults (>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults Using Currently a Nucleus Cochlear Implant | Adults (>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score of the French MBAA2 Sentence Recognition Test in Quiet | Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of <90/100 correct sentence. | Posted | Count of Participants | Participants | 1 month post activation |
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|
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Deaths, serious adverse events and non-serious adverse events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults Using Currently a Nucleus Cochlear Implant | Adults (>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2021 | Oct 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| years |
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| Sex: Female, Male | Sex/ gender information has not been collected. | Count of Participants | Participants |
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| Race (NIH/OMB) | Race information has not been collected. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |