Trial Outcomes & Findings for Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults (NCT NCT05265260)
NCT ID: NCT05265260
Last Updated: 2024-04-05
Results Overview
Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \<90/100 correct sentence.
COMPLETED
32 participants
1 month post activation
2024-04-05
Participant Flow
32 participants were recruited between 21 April 2022 and 24 August 2022. The aim was to recruit 30 participants with data for the primary endpoint. As it was noted during the data collection period that data was missing, the number was increased to 32.
Participant milestones
| Measure |
Adults Using Currently a Nucleus Cochlear Implant
Adults (\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
Baseline characteristics by cohort
| Measure |
Adults Using Currently a Nucleus Cochlear Implant
n=32 Participants
Adults (\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
|
|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 13.5 • n=32 Participants
|
|
Region of Enrollment
France
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 1 month post activationParticipants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of \<90/100 correct sentence.
Outcome measures
| Measure |
Adults Using Currently a Nucleus Cochlear Implant
n=32 Participants
Adults (\>18 years) unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
|
|---|---|
|
Score of the French MBAA2 Sentence Recognition Test in Quiet
Good performer
|
13 Participants
|
|
Score of the French MBAA2 Sentence Recognition Test in Quiet
Bad performer
|
19 Participants
|
Adverse Events
Adults Using Currently a Nucleus Cochlear Implant
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