An interventional study of Personal sound amplification products in Hearing Loss, Age-Related, sponsored by Rotman Research Institute at Baycrest. Completed at 1 site in Canada. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Rotman Research Institute at Baycrest · Not applicable, Interventional, and Basic science
Mild to moderate hearing loss remains undertreated, largely because of the high cost of hearing aids. A promising and much less expensive alternative is the use of personal sound amplification products (PSAPs), which are electronic, portable, over-the-counter devices that amplify sound. Studies have shown that the use of PSAPs provides significant hearing benefits and improves the quality of life for older adults with mild to moderate hearing loss. However, there is insufficient data to determine the impact of PSAPs use on speech processing in the brain.
The purpose of this study is to use electroencephalography (EEG) measurements to assess the neurobiological and behavioral effects of PSAPs on speech perception in noise in individuals with mild to moderate hearing loss.
The investigators expect that the PSAPs use will result in an immediate improvement in the ability to perceive speech-in-noise, supporting that these hearing devices may be a means of restoring communication skills in people with mild to moderate hearing loss. Behavioral benefits will be associated with increased brain activity in auditory regions and connectivity between auditory and speech regions in the brain.
This study will consist of two sessions of 3 hours each. On one session, participants will perform the speech-in-noise task without hearing devices and on the other session, participants will perform the speech-in-noise task while wearing personal sound amplification products. The order of the sessions will be counterbalanced across participants. The speech-in-noise task consists in a word discrimination task in babble noise at three signal-to-noise ratios. On each trial, the task is to determine whether two words are identical or different.
65 studies on the registry are indexed under Presbycusis; 23 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 44 interventional studies indexed under Presbycusis.
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Exclusion Criteria:
Speech perception will be evaluated using personal sound amplification products.
Device: Personal sound amplification products
Speech perception will be evaluated without using hearing devices.
Participants will be tested with bilateral personal sound amplification products.
Percentage of Correct Responses With and Without PSAPs
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
Time frame: 1 hour
Reaction Time With and Without PSAPs
Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
Time frame: 1 hour
Quick Speech In Noise Score With and Without PSAPs
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.
Time frame: 1 hour
Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs
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).
Time frame: 1 hour
Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs
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).
Time frame: 1 hour
Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs
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).
Time frame: 1 hour
Self-reported Measure of Listening Effort With and Without PSAPs
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.
Time frame: 1 hour
72 participants were screened for eligibility between March 1, 2022 and September 31, 2022 by telephone interview at Baycrest Hospital in Toronto, Canada.
| Milestone | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
| Milestone | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products |
|---|---|---|
| Started | 16 | 16 |
| Completed | 15 | 13 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Milestone | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products |
|---|---|---|
| Started | 15 | 13 |
| Completed | 15 | 13 |
| Not completed | 0 | 0 |
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
| percentage of correct answers | Personal Sound Amplification Products | Control |
|---|---|---|
| Percentage of Correct Responses With and Without PSAPs | 85.2 (83.2 to 87.4) | 84.0 (81.9 to 86.0) |
Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
| milliseconds | Personal Sound Amplification Products | Control |
|---|---|---|
| Reaction Time With and Without PSAPs | 528.7 ± 155.1 | 502.0 ± 145.9 |
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.
| dB | Personal Sound Amplification Products | Control |
|---|---|---|
| Quick Speech In Noise Score With and Without PSAPs | 3.6 ± 2.2 | 4.6 ± 2.4 |
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).
| percentage of power change | Personal Sound Amplification Products | Control |
|---|---|---|
| Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs | -0.10 ± 0.11 | -0.12 ± 0.12 |
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).
| percentage of power change | Personal Sound Amplification Products | Control |
|---|---|---|
| Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs | -0.09 ± 0.14 | -0.08 ± 0.15 |
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).
| percentage of power change | Personal Sound Amplification Products | Control |
|---|---|---|
| Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs | -0.08 ± 0.11 | -0.01 ± 0.13 |
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.
| score on a scale | Personal Sound Amplification Products | Control |
|---|---|---|
| Self-reported Measure of Listening Effort With and Without PSAPs | 3.8 ± 1.1 | 4.2 ± 0.9 |
Collected over Adverse events were collected during the first and second sessions, over a period of approximately one week.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personal Sound Amplification Products | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Control | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products | Total |
|---|---|---|---|
| Mean | 74 ± 6.6 | 72.23 ± 6.25 | 73.18 ± 6.38 |
| Sex: Female, Male(Participants) | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 6 | 3 | 9 |
| Race and Ethnicity Not Collected(Participants) | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Personal Sound Amplification Products First, Then Control | Control First, Then Personal Sound Amplification Products | Total |
|---|---|---|---|
| Canada | 15 | 13 | 28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Demographic and health information, behavioral results, and EEG recordings will be shared on an open platform only if participants consent. The data will be anonymized using a random generic code. No personally identifiable data will be shared. The code and stimuli of the task will also be shared on the platform.
Supporting information: Study protocol, Analytic code
Time frame: The data will be shared when the article is published and will remain accessible as long as possible.
Access criteria: Data will be shared on an open platform to be determined. The web address of the data sharing will be inserted in the article, and anyone can access the data from this link.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Rotman Research Institute at Baycrest