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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..
The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor.
To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP1000 Sound Processor followed by the CP1110 Sound Processor | Experimental | All study subjects were provided with a unique identifier. The ones that ended in an odd number were administered the CP1000 Sound Processor followed by the CP1110 Sound Processor. |
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| CP1110 Sound Processor followed by the CP1000 Sound Processor | Experimental | All study subjects were provided with a unique identifier. The ones that ended in an even number were administered the CP1110 Sound Processor followed by the CP1000 Sound Processor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP1110 | Device | Sound Processor |
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| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise | Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome. | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Sydney | Sydney | New South Wales | 2109 | Australia |
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21 subjects were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | CP1000 Sound Processor Followed by the CP1110 Sound Processor | All study subjects were provided with a unique identifier. The ones that ended in an odd number were administered the CP1000 Sound Processor followed by the CP1110 Sound Processor. |
| FG001 | CP1110 Sound Processor Followed by the CP1000 Sound Processor | All study subjects were provided with a unique identifier. The ones that ended in an even number were administered the CP1110 Sound Processor followed by the CP1000 Sound Processor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Baseline characteristics are combined across the 2 arms. |
| 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, Customized | Median |
| 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 | Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise | Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome. | Posted | Mean | 95% Confidence Interval | decibels | One day |
|
2 months
All study subjects were provided with a unique identifier .The ones that ended in an odd number were administered the CP1000 Sound Processor followed by the CP1110 Sound Processor, and the opposite order was used for participants with an even numbered subject identifier.
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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 | CP1000 Sound Processor | All study participants whilst using CP1000 Sound Processor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Limited | +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 | Yes | No | No | Study Protocol | Sep 16, 2021 | Jan 28, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2022 | Jun 17, 2022 | SAP_001.pdf |
prospective, pre-market, Multi-site, non-randomized.
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| CP1000 | Device | Sound Processor |
|
| One day |
| Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on. | One day |
| Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score of CP1110 sound processor ForwardFocus ON (Moderate) vs CP1000 sound processor Signal-to-Noise Ration-Noise Reduction) On. | One Day |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on. | Posted | Mean | 95% Confidence Interval | percentage of correct words | One day |
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| Secondary | Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on. | Posted | Mean | 95% Confidence Interval | percentage of correct words | One day |
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| Secondary | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score of CP1110 sound processor ForwardFocus ON (Moderate) vs CP1000 sound processor Signal-to-Noise Ration-Noise Reduction) On. | Posted | Mean | 95% Confidence Interval | percentage of correct words | One Day |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | CP1110 Sound Processor | All study participants whilst using CP1110 Sound Processor | 0 | 20 | 0 | 20 | 0 | 20 |
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