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| Name | Class |
|---|---|
| Trium Clinical Consulting | INDUSTRY |
| Avania | INDUSTRY |
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This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.
Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.
Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.
A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.
The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Other | Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPACE | Device | SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants. |
| Measure | Description | Time Frame |
|---|---|---|
| Monosyllabic Word in Quiet Scores. | Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome | One Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Komal Arora | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEARnet Clinical Studies | Carlton | Victoria | 3052 | Australia | ||
| Cochlear Ltd. Melbourne |
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The participant flow includes only one group as this was a repeated measures, single-arm study where all participants were exposed to all sound processing strategies. Data from the same participants was collected multiple times across different conditions. The focus was on assessing effects within the same group under varying conditions, making it a single-arm design with repeated measurements on each participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). SPACE: SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants. OPAL-SPACE: OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively. ACE: Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy. Cochlear Device Interface (CDI) Tool: For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: CDI Tool. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). SPACE: SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants. OPAL-SPACE: OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively. ACE: Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy. Cochlear Device Interface (CDI) Tool: For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: CDI Tool. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Monosyllabic Word in Quiet Scores. | Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome | Posted | Mean | Standard Deviation | Percentage of words repeated correctly | One Day |
|
6 weeks (Time from treatment assignment to End of Study visit)
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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 | All Participants | Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | 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 | Jun 3, 2022 | Nov 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
|
| OPAL-SPACE | Device | OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively. |
|
| ACE | Device | Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy. |
|
|
| Cochlear Device Interface (CDI) Tool | Device | For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface. |
|
| East Melbourne |
| 3002 |
| Australia |
| AZ Sint-Jan Brugge-Oostende AV | Bruges | 8000 | Belgium |
| Cochlear Technology Centre Belgium | Mechelen | 2800 | Belgium |
| Sint-Augustinus Antwerpen | Wilrijk | 2610 | Belgium |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Clinical Device in Test Ear | Count of Participants | Participants |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |