Trial Outcomes & Findings for Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09 (NCT NCT04578457)
NCT ID: NCT04578457
Last Updated: 2021-10-05
Results Overview
Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes \& latencies (micro-Siemens \& milliseconds).
COMPLETED
NA
19 participants
6 weeks
2021-10-05
Participant Flow
Participant milestones
| Measure |
Randomized Condition
This was a crossover "within subject design" study in which all participants undertook all study conditions.
These conditions consisted of different hearing aid settings, and were interleaved within study appointments.
Accordingly, the different conditions are reported here as study 'Periods' to avoid participants being included multiple times in the overall protocol count.
This means there will be a discrepancy whereby the number starting a period will be greater than the number completing the previous 'period'. Of course this is simply due to the fact that the study 'periods' as reported are not chronological.
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|---|---|
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Hearing Aid Without NR Enabled (0)
STARTED
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19
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Hearing Aid Without NR Enabled (0)
COMPLETED
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17
|
|
Hearing Aid Without NR Enabled (0)
NOT COMPLETED
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2
|
|
Hearing Aid With NR (1)
STARTED
|
19
|
|
Hearing Aid With NR (1)
COMPLETED
|
17
|
|
Hearing Aid With NR (1)
NOT COMPLETED
|
2
|
|
Hearing Aid With NR (2)
STARTED
|
19
|
|
Hearing Aid With NR (2)
COMPLETED
|
17
|
|
Hearing Aid With NR (2)
NOT COMPLETED
|
2
|
|
Hearing Aid With NR (4)
STARTED
|
19
|
|
Hearing Aid With NR (4)
COMPLETED
|
17
|
|
Hearing Aid With NR (4)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Randomized Condition
This was a crossover "within subject design" study in which all participants undertook all study conditions.
These conditions consisted of different hearing aid settings, and were interleaved within study appointments.
Accordingly, the different conditions are reported here as study 'Periods' to avoid participants being included multiple times in the overall protocol count.
This means there will be a discrepancy whereby the number starting a period will be greater than the number completing the previous 'period'. Of course this is simply due to the fact that the study 'periods' as reported are not chronological.
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|---|---|
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Hearing Aid Without NR Enabled (0)
Withdrawal by Subject
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2
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Hearing Aid With NR (1)
Withdrawal by Subject
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2
|
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Hearing Aid With NR (2)
Withdrawal by Subject
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2
|
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Hearing Aid With NR (4)
Withdrawal by Subject
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Cohort
n=19 Participants
This study was a crossover design, therefore there was only a single study group.
This group undertook measures under each of the study conditions.
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|---|---|
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Age, Continuous
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74.95 years
STANDARD_DEVIATION 7.42 • n=19 Participants
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Sex: Female, Male
Female
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4 Participants
n=19 Participants
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Sex: Female, Male
Male
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15 Participants
n=19 Participants
|
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Region of Enrollment
Switzerland
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19 Participants
n=19 Participants
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PRIMARY outcome
Timeframe: 6 weeksPopulation: The data from some participants had to be excluded from the analysis. Due to the noisy nature of physiological data, in some cases we were unable to collect enough valid, artefact-free data to analyse. Where this was the case, we discounted the participant from analyses. As we only contrasted NR(0) vs NR(1) and NR(2) vs NR(3) (and collected respective data at different study appointments), there is a slight discrepancy in the number of participants analysed for these study arms.
Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes \& latencies (micro-Siemens \& milliseconds).
Outcome measures
| Measure |
Hearing Aid Without NR(0) Enabled
n=15 Participants
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
|
Hearing Aid With NR (1)
n=15 Participants
Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
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Hearing Aid With NR(2)
n=16 Participants
Hearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
|
Hearing Aid With NR(3)
n=16 Participants
Hearing Aid with Noise Reduction III (NR) enabled.
Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
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|---|---|---|---|---|
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Differences in Event-related-skin-conductance
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0.221 micro Siemens
Interval 0.176 to 0.267
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0.189 micro Siemens
Interval 0.15 to 0.227
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0.147 micro Siemens
Interval 0.099 to 0.195
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0.126 micro Siemens
Interval 0.099 to 0.153
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PRIMARY outcome
Timeframe: 6 weeksPopulation: The data from some participants had to be excluded from the analysis. Due to the noisy nature of physiological data, in some cases we were unable to collect enough valid, artefact-free data to analyse. Where this was the case, we discounted the participant from analyses.
Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations. We use the unit: pixels. The size of a pixel in 1mm\^2 is relative to the distance between the eye and the camera. Even though participants heads were placed on a chin rest that was always the same distance from the camera, the distance between the individual eye and the camera can still be different due to differences in participants' anatomies. Thus, pupil dilation are often reported relative to an individuals' baseline, for example as percent change relative to the baseline. Therefore, we use the unit: pixels, as the use of mm\^2 may be inaccurate.
Outcome measures
| Measure |
Hearing Aid Without NR(0) Enabled
n=11 Participants
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
|
Hearing Aid With NR (1)
n=11 Participants
Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
|
Hearing Aid With NR(2)
n=11 Participants
Hearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
|
Hearing Aid With NR(3)
n=11 Participants
Hearing Aid with Noise Reduction III (NR) enabled.
Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
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Differences in Event-related-pupil-dilation (ERPDs)
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217.713 pixels
Interval 154.747 to 280.689
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217.301 pixels
Interval 164.876 to 269.726
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158.732 pixels
Interval 113.199 to 204.265
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186.526 pixels
Interval 119.151 to 253.9
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SECONDARY outcome
Timeframe: 6 weeksPopulation: By the time this outcome measure was performed, 1 of the original participants had withdrawn from the study. Therefore, data for 18 participants was analysed.
Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Outcome measures
| Measure |
Hearing Aid Without NR(0) Enabled
n=18 Participants
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
|
Hearing Aid With NR (1)
n=18 Participants
Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
|
Hearing Aid With NR(2)
n=18 Participants
Hearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
|
Hearing Aid With NR(3)
n=18 Participants
Hearing Aid with Noise Reduction III (NR) enabled.
Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
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Oldenburg Sentence Test
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92.778 Percentage of correct words
Standard Deviation 3.296
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88.611 Percentage of correct words
Standard Deviation 6.709
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96.157 Percentage of correct words
Standard Deviation 2.271
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94.398 Percentage of correct words
Standard Deviation 4.607
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SECONDARY outcome
Timeframe: 6 weeksPopulation: By the time this outcome measure was performed, 2 of the original participants had withdrawn from the study. Therefore, data for 17 participants was analysed.
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as secondary outcome measure, are collected in the laboratory. The scale ranges from 0 "very bad" to 6 "very good" in increments of 1. Individual sound quality rating from participants are averaged over 3 different acoustic scenes for each hearing aid program.
Outcome measures
| Measure |
Hearing Aid Without NR(0) Enabled
n=17 Participants
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
|
Hearing Aid With NR (1)
n=17 Participants
Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
|
Hearing Aid With NR(2)
n=17 Participants
Hearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
|
Hearing Aid With NR(3)
n=17 Participants
Hearing Aid with Noise Reduction III (NR) enabled.
Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
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|---|---|---|---|---|
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Sound Quality Ratings
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3.275 score on a scale
Standard Error 0.263
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3.230 score on a scale
Standard Error 0.107
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3.054 score on a scale
Standard Error 0.208
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3.157 score on a scale
Standard Error 0.136
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SECONDARY outcome
Timeframe: 6 weeksPopulation: By the time this outcome measure was performed, 2 of the original participants had withdrawn from the study. Therefore, 17 participants had measurements for this outcome measure made. For 5 participants it was not possible to measure an STM threshold reliably at all test occasions. Where this was the case, these participants were excluded from analyses.
Stimuli which contain simultaneous frequency and amplitude modulations of a wide-band noise carrier are presented to the participants. The depth of the modulations is systematically varied and the individual modulation detection thresholds are recorded as a broadband decibel (dB) value. For each participant 4 measures were made and averaged to give a mean STM threshold.
Outcome measures
| Measure |
Hearing Aid Without NR(0) Enabled
n=12 Participants
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid without NR enabled: Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
|
Hearing Aid With NR (1)
Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(1): Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
|
Hearing Aid With NR(2)
Hearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(2): Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
|
Hearing Aid With NR(3)
Hearing Aid with Noise Reduction III (NR) enabled.
Hearing Aid with NR(3): Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
|
|---|---|---|---|---|
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Spectro-temporal-modulation Detection Thresholds (STM)
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-8.181 decibel
Standard Error 0.617
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—
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—
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksThe Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible according to a given order. In version A the order is given by increasing digit number (i.e. 1-25) while in version B the order is given by alternating digits and letters (i.e. 1-A-2-B-3-C…). The data, serving as an outcome measure, are time-to-complete the set in seconds.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksThe digit-span task is used to measure working memory's number storage capacity. Participants will see a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered, which means that the participant recalls two sequences out of a maximum of three sequences correct. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sentence in normal or reverse order.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksThe Go/No-go task measures inhibitory control. Participants are asked to respond to a Go stimulus as fast as possible but not respond to a No-go stimulus. Go stimuli are presented at a rate much higher than the No-go stimuli to elicit prepotent motor activity. The outcome measure of this task is the number of commission errors (i.e. responding to a No-go stimuli) a participant commits as a measure of their ability to stop prepotent motor activity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksBlood volume pulse will be recorded from participants during the performance of the auditory task (non-invasively with a photoplethysmographic (PPG) sensor). Analyses will be carried out on the data recorded during a time window following each auditory stimulus (relative to baseline activity). It is planned to analyze event-related changes in pulse rate and amplitude (beats per minute).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksRespiration rates will be recorded from participants during the auditory task using a belt placed under the ribcage. This data will only be used to control for changes in breathing patterns which may influence skin conductance measurements.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksSkin temperature will be recorded from participants during the auditory task using a small thermometer attached to the outside of the little finger (non-dominant hand). This data will only be used to control for changes in temperature which may influence skin conductance measurements.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksTympanometry will be used to assess the mobility of the eardrum, prior to recording Acoustic Reflex Thresholds (ARTs). Compliance \[ml\], Middle Ear Pressure \[daPa\] and ear canal volume \[ml\] will be recorded and checked that they fall within normal limits. Where this is the case, ARTs will be measured using 0.5, 1 \& 2 kHz stimulus tones ipsi- and contralaterally for each ear. The resulting outcome measure will be the threshold \[dB\] required at each frequency and ear arrangement for a stapedial reflex to be present.
Outcome measures
Outcome data not reported
Adverse Events
Study Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Cohort
n=19 participants at risk
This study was a crossover design, therefore there was only a single study group.
This group undertook measures under each of the study conditions. These conditions were undertaken in an interleaved fashion during the same study appointment.
As such it is not possible to attribute the adverse event reported to any single condition.
We therefore report the adverse events here as a function of the entire study population.
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|---|---|
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General disorders
Positive test for COVID-19
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5.3%
1/19 • 7 months
This study was a crossover design, therefore there was only a single study group. This group undertook measures under each of the study conditions. These conditions were undertaken in an interleaved fashion during the same study appointment. As such it is not possible to attribute the adverse event reported to any single condition. We therefore report the adverse events here as a function of the entire study population.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place