Trial Outcomes & Findings for Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants (NCT NCT02644343)
NCT ID: NCT02644343
Last Updated: 2020-11-24
Results Overview
Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
2-4 weeks post remote programming session
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
Remote Programming Group
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Remote Programming Group
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remote Programming Group
n=40 Participants
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants.
|
|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 26 • n=40 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
|
Internal Implant Model
CI24R
|
3 Participants
n=40 Participants
|
|
Internal Implant Model
CI24RE
|
23 Participants
n=40 Participants
|
|
Internal Implant Model
CI422
|
8 Participants
n=40 Participants
|
|
Internal Implant Model
CI500 series
|
6 Participants
n=40 Participants
|
|
Sound Processor Model
Nucleus 5
|
17 Participants
n=40 Participants
|
|
Sound Processor Model
Nucleus 6
|
23 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 2-4 weeks post remote programming sessionSubjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.
Outcome measures
| Measure |
Remote Programming Group
n=39 Participants
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants.
|
|---|---|
|
Speech Perception on Monosyllabic Word Test, CNC Words
Live Audiologist MAP
|
70.5 percentage of words correct
Standard Deviation 18.6
|
|
Speech Perception on Monosyllabic Word Test, CNC Words
Facilitated Remote MAP
|
72.4 percentage of words correct
Standard Deviation 18.7
|
|
Speech Perception on Monosyllabic Word Test, CNC Words
Unassisted Remote MAP
|
72.5 percentage of words correct
Standard Deviation 21.3
|
Adverse Events
Remote Programming Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Remote Programming Group
n=40 participants at risk
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants.
|
|---|---|
|
Social circumstances
Car Accident
|
2.5%
1/40 • Number of events 1 • 1 year, 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place