Trial Outcomes & Findings for Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients. (NCT NCT05476328)
NCT ID: NCT05476328
Last Updated: 2025-02-13
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
One Day
Results posted on
2025-02-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
ACE Strategy
|
8
|
|
Overall Study
SPACE Strategy
|
8
|
|
Overall Study
OPAL-SPACE Strategy
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=8 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.
|
|---|---|
|
Age, Continuous
|
69 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
|
Clinical Device in Test Ear
N7 CI24RE
|
3 Participants
n=8 Participants
|
|
Clinical Device in Test Ear
N7 CI512
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: One DayMonosyllabic 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
Outcome measures
| Measure |
All Participants
n=8 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 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 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 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.
|
|---|---|
|
Monosyllabic Word in Quiet Scores.
ACE Strategy
|
51 Percentage of words repeated correctly
Standard Deviation 14.97
|
|
Monosyllabic Word in Quiet Scores.
SPACE Strategy
|
51.25 Percentage of words repeated correctly
Standard Deviation 10.95
|
|
Monosyllabic Word in Quiet Scores.
OPAL-SPACE Strategy
|
48.50 Percentage of words repeated correctly
Standard Deviation 14.45
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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