Trial Outcomes & Findings for CP1110 Sound Processor Feasibility (NCT NCT04898673)
NCT ID: NCT04898673
Last Updated: 2025-02-11
Results Overview
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.
COMPLETED
NA
21 participants
One day
2025-02-11
Participant Flow
21 subjects were recruited.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
CP1110 Sound Processor
|
10
|
10
|
|
Overall Study
CP1000 Sound Processor
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Screenfail
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Baseline characteristics are combined across the 2 arms.
|
|---|---|
|
Age, Customized
|
64.5 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: One dayPaired 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.
Outcome measures
| Measure |
CP1000
n=20 Participants
All subjects tested using CP1000
|
CP1110
n=20 Participants
All subjects tested using CP1110
|
|---|---|---|
|
Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise
|
-6.07 decibels
Interval -6.07 to -4.47
|
-11.30 decibels
Interval -13.28 to -9.32
|
SECONDARY outcome
Timeframe: One dayPaired 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.
Outcome measures
| Measure |
CP1000
n=20 Participants
All subjects tested using CP1000
|
CP1110
n=20 Participants
All subjects tested using CP1110
|
|---|---|---|
|
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
|
57.5 percentage of correct words
Interval 51.67 to 63.33
|
58.10 percentage of correct words
Interval 51.56 to 64.64
|
SECONDARY outcome
Timeframe: One dayPaired 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.
Outcome measures
| Measure |
CP1000
n=20 Participants
All subjects tested using CP1000
|
CP1110
n=20 Participants
All subjects tested using CP1110
|
|---|---|---|
|
Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
|
60.90 percentage of correct words
Interval 54.98 to 66.82
|
57.15 percentage of correct words
Interval 50.26 to 64.04
|
SECONDARY outcome
Timeframe: One DayPaired 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.
Outcome measures
| Measure |
CP1000
n=20 Participants
All subjects tested using CP1000
|
CP1110
n=20 Participants
All subjects tested using CP1110
|
|---|---|---|
|
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
|
57.50 percentage of correct words
Interval 51.67 to 63.33
|
56.35 percentage of correct words
Interval 50.33 to 62.37
|
Adverse Events
CP1000 Sound Processor
CP1110 Sound Processor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place