Trial Outcomes & Findings for Variability In Hearing Aid Outcomes In Older Adults (NCT NCT02448706)
NCT ID: NCT02448706
Last Updated: 2020-11-17
Results Overview
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
Hearing Aid Fitting Order A
High level of signal manipulation (5 weeks), then low level of signal manipulation (5 weeks)
|
Hearing Aid Fitting Order B
Low level of signal manipulation (5 weeks), then high level of signal manipulation (5 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
Withdrew for Personal Reasons
|
1
|
1
|
|
Overall Study
Completed Baseline Testing
|
24
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Hearing Aid Fitting Order A
High level of signal manipulation (5 weeks), then low level of signal manipulation (5 weeks)
|
Hearing Aid Fitting Order B
Low level of signal manipulation (5 weeks), then high level of signal manipulation (5 weeks)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Variability In Hearing Aid Outcomes In Older Adults
Baseline characteristics by cohort
| Measure |
All Study Participants
n=47 Participants
All study participants received the same baseline measures, regardless of the hearing aid fitting order to which they were randomized
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
|
Reading span task
|
34 percentage of correctly recalled words
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksParticipants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
Outcome measures
| Measure |
High Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
Low Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
|---|---|---|
|
Speech Intelligibility Score
|
69 percentage of correct responses
Standard Deviation 18
|
78 percentage of correct responses
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 6 weeksThe listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
Outcome measures
| Measure |
High Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
Low Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
|---|---|---|
|
Effectiveness of Aural Rehabilitation (EAR)
|
60.0 score on a scale
Standard Deviation 23.3
|
74.2 score on a scale
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: 6 weeksListener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
Outcome measures
| Measure |
High Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
Low Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
|---|---|---|
|
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
|
6.47 score on a scale
Standard Deviation 1.4
|
6.95 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 6 weeksAverage number of hours per day the hearing aid was worn.
Outcome measures
| Measure |
High Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
Low Level of Signal Manipulation
n=40 Participants
Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial.
|
|---|---|---|
|
Adherence
|
9 hours per day
Standard Deviation 3.7
|
9 hours per day
Standard Deviation 3.4
|
Adverse Events
Hearing Aid Fitting A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hearing Aid Fitting B
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