Trial Outcomes & Findings for Remote Microphone Candidacy Study (NCT NCT03897634)
NCT ID: NCT03897634
Last Updated: 2021-06-10
Results Overview
Self assessment, disability based inventory that is used to document outcomes of hearing aid fittings. The APHAB uses a percentile scale (Percent of Problems). This measure has 4 subscales: Ease of communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). A lower score indicates a better outcome. We will look at both the global change (defined as EC, RV, and BN scores improving by at least 5 points each) and individual subscales (For EC, RV, or BN a change in 22 points is considered significant and for AV a change of 31 points is needed to be considered significant).
COMPLETED
NA
22 participants
Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.
2021-06-10
Participant Flow
Participant milestones
| Measure |
Experienced Hearing Aid User
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experienced Hearing Aid User
n=22 Participants
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
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|---|---|
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Age, Continuous
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75.5 years
n=22 Participants
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Sex: Female, Male
Female
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10 Participants
n=22 Participants
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Sex: Female, Male
Male
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12 Participants
n=22 Participants
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB: Overall Baseline
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28.9 % of problems
n=17 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB Background Noise Baseline
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37.0 % of problems
n=22 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB Aversiveness Baseline
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39.7 % of problems
n=22 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB Ease of Communication Baseline
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20.15 % of problems
n=22 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB Reverberation Baseline
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30.4 % of problems
n=22 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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% of words repeated correctly in a sentence recog. task with variable levels of background noise: HA
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61.0 % Correct
STANDARD_DEVIATION 35.6 • n=17 Participants • Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, and their opportunity for social activity and listening environments drastically changed from their baseline measurements.
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PRIMARY outcome
Timeframe: Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.Population: Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
Self assessment, disability based inventory that is used to document outcomes of hearing aid fittings. The APHAB uses a percentile scale (Percent of Problems). This measure has 4 subscales: Ease of communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). A lower score indicates a better outcome. We will look at both the global change (defined as EC, RV, and BN scores improving by at least 5 points each) and individual subscales (For EC, RV, or BN a change in 22 points is considered significant and for AV a change of 31 points is needed to be considered significant).
Outcome measures
| Measure |
Experienced Hearing Aid User
n=17 Participants
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
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|---|---|
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Overall APHAB Change
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7.64 % of Problems (Change from baseline)
Interval -11.7 to 24.8
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change in BN
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12.5 % of Problems (Change from baseline)
Interval -5.8 to 35.1
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change in RV
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4.8 % of Problems (Change from baseline)
Interval -22.8 to 37.7
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change in EC
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6.3 % of Problems (Change from baseline)
Interval -1.5 to 23.7
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Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change in AV
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-2.6 % of Problems (Change from baseline)
Interval -70.3 to 35.2
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SECONDARY outcome
Timeframe: Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.Questionnaire, clinical patient interview design where participants respond on a scale of 0 to 10, with 10 indicating perfect hearing ability and 0 indicating complete inability.There are 3 subscales calculated by averaged the responses to the questions for each subscale. A change of 2 points is considered a moderate effect with increase in score indicating improvement.
Outcome measures
| Measure |
Experienced Hearing Aid User
n=17 Participants
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
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|---|---|
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Change in Speech, Spatial, and Qualities of Hearing (SSQ)
Quality
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1.1 score on a scale
Interval -1.2 to 4.9
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Change in Speech, Spatial, and Qualities of Hearing (SSQ)
Speech
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1.7 score on a scale
Interval 0.0 to 3.6
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Change in Speech, Spatial, and Qualities of Hearing (SSQ)
Spatial
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0.6 score on a scale
Interval -0.9 to 5.1
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SECONDARY outcome
Timeframe: End of trial: Objective speech intel was collected in one session at the end of the 30 day trial with the remote microphone. Order of conditions (Hearing aid only and Hearing Aid+ Remote Mic) was randomized.Population: Participants who did not complete their study participation prior to the start of Covid shutdown are excluded, as their opportunity for social activity and listening environments drastically changed from their baseline measurements.
Participants had to repeat sentences presented to them in varying levels of background noise. Sentences are scores based on the number of key words (5) they get correct.
Outcome measures
| Measure |
Experienced Hearing Aid User
n=17 Participants
Single arm study, all participants in this arm. Participants will be experienced hearing aid users.
Remote Microphone: Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
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|---|---|
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% of Words Repeated Correctly in a Sentence Recognition Task With Variable Levels of Background Noise
Hearing Aid Only
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60.0 % Correct
Interval 0.0 to 100.0
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% of Words Repeated Correctly in a Sentence Recognition Task With Variable Levels of Background Noise
Hearing aid + Remote Mic
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82.7 % Correct
Interval 0.0 to 100.0
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Adverse Events
Experiences Hearing Aid User
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