Trial Outcomes & Findings for Effects of PSAPs on Speech Processing (NCT NCT05076045)
NCT ID: NCT05076045
Last Updated: 2024-12-05
Results Overview
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
COMPLETED
NA
32 participants
1 hour
2024-12-05
Participant Flow
72 participants were screened for eligibility between March 1, 2022 and September 31, 2022 by telephone interview at Baycrest Hospital in Toronto, Canada.
32 of the 72 participants were randomized. Of those who were not randomized, 22 did not meet the inclusion criteria, 14 declined to participate and four had other reasons.
Participant milestones
| Measure |
Personal Sound Amplification Products First, Then Control
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products during the first session. After a one-week washout period, they were retested for speech-in-noise perception while not using a device.
|
Control First, Then Personal Sound Amplification Products
Participants were tested for speech perception in noise while using no devices during the first session. After a one-week washout period, they were retested for speech-in-noise perception while using bilateral personal sound amplification products.
|
|---|---|---|
|
First Intervention (3 Hours)
STARTED
|
16
|
16
|
|
First Intervention (3 Hours)
COMPLETED
|
16
|
16
|
|
First Intervention (3 Hours)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
16
|
16
|
|
Washout (1 Week)
COMPLETED
|
15
|
13
|
|
Washout (1 Week)
NOT COMPLETED
|
1
|
3
|
|
Second Intervention (3 Hours)
STARTED
|
15
|
13
|
|
Second Intervention (3 Hours)
COMPLETED
|
15
|
13
|
|
Second Intervention (3 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Personal Sound Amplification Products First, Then Control
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products during the first session. After a one-week washout period, they were retested for speech-in-noise perception while not using a device.
|
Control First, Then Personal Sound Amplification Products
Participants were tested for speech perception in noise while using no devices during the first session. After a one-week washout period, they were retested for speech-in-noise perception while using bilateral personal sound amplification products.
|
|---|---|---|
|
Washout (1 Week)
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Personal Sound Amplification Products First, Then Control
n=15 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products during the first session. After a one-week washout period, they were retested for speech-in-noise perception while not using a device.
|
Control First, Then Personal Sound Amplification Products
n=13 Participants
Participants were tested for speech perception in noise while using no devices during the first session. After a one-week washout period, they were retested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 6.6 • n=15 Participants
|
72.23 years
STANDARD_DEVIATION 6.25 • n=13 Participants
|
73.18 years
STANDARD_DEVIATION 6.38 • n=28 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=15 Participants
|
10 Participants
n=13 Participants
|
19 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=15 Participants
|
3 Participants
n=13 Participants
|
9 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
15 participants
n=15 Participants
|
13 participants
n=13 Participants
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: All participants who completed all study visits were included in the analysis.
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
Outcome measures
| Measure |
Personal Sound Amplification Products
n=28 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=28 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Percentage of Correct Responses With and Without PSAPs
|
85.2 percentage of correct answers
Interval 83.2 to 87.4
|
84.0 percentage of correct answers
Interval 81.9 to 86.0
|
PRIMARY outcome
Timeframe: 1 hourPopulation: All participants who completed all study visits were included in the analysis. Data from one participant was lost due to a technical issue. Additionally, one participant was excluded because their reaction time values exceeded 3 times the interquartile range.
Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
Outcome measures
| Measure |
Personal Sound Amplification Products
n=26 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=26 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Reaction Time With and Without PSAPs
|
528.7 milliseconds
Standard Deviation 155.1
|
502.0 milliseconds
Standard Deviation 145.9
|
PRIMARY outcome
Timeframe: 1 hourPopulation: All participants who completed all study visits were included in the analysis.
Performance on the QuickSIN when using PSAPs and when using no device. The QuickSIN measures the signal-to-noise ratio loss. A high score indicates poorer speech understanding in noise.
Outcome measures
| Measure |
Personal Sound Amplification Products
n=28 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=28 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Quick Speech In Noise Score With and Without PSAPs
|
3.6 dB
Standard Deviation 2.2
|
4.6 dB
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 1 hourPopulation: One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data.
Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a low noise condition (signal-to-noise ratio of +3 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).
Outcome measures
| Measure |
Personal Sound Amplification Products
n=25 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=25 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs
|
-0.10 percentage of power change
Standard Deviation 0.11
|
-0.12 percentage of power change
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 1 hourPopulation: One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data.
Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a medium noise condition (signal-to-noise ratio of 0 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).
Outcome measures
| Measure |
Personal Sound Amplification Products
n=25 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=25 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs
|
-0.09 percentage of power change
Standard Deviation 0.14
|
-0.08 percentage of power change
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 1 hourPopulation: One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data.
Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a high noise condition (signal-to-noise ratio of -3 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).
Outcome measures
| Measure |
Personal Sound Amplification Products
n=25 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=25 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs
|
-0.08 percentage of power change
Standard Deviation 0.11
|
-0.01 percentage of power change
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 1 hourPopulation: All participants who completed all study visits were included in the analysis.
Self-reported listening effort in the speech-in-noise task when using PSAPs and when using no device. Participants used a seven-point Likert scale to rate the listening effort required to complete the speech-in-noise task. The specific question was: "Using the scale in front of you, can you estimate how much effort it took you to understand the words in the presence of background noise? If you think that the amount of effort was between two numbers on the scale, it is fine for you to pick a fraction," with number 1 corresponding to "No effort" and number 7 corresponding to "Extreme effort." A high score indicates a greater listening effort.
Outcome measures
| Measure |
Personal Sound Amplification Products
n=28 Participants
Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products.
|
Control
n=28 Participants
Participants were tested for speech perception in noise while using no devices.
|
|---|---|---|
|
Self-reported Measure of Listening Effort With and Without PSAPs
|
3.8 score on a scale
Standard Deviation 1.1
|
4.2 score on a scale
Standard Deviation 0.9
|
Adverse Events
Personal Sound Amplification Products
Control
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