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Effects of PSAPs on Speech Processing
NA trial testing Personal sound amplification products in Hearing Loss, Age-Related in 32 participants. Completed in 1 October 2022.
| Lead sponsor | Rotman Research Institute at Baycrest |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 1 March 2022 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across Canada |
Rotman Research Institute at Baycrest
Adults 60 to 90, any sex, with Hearing Loss, Age-Related. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | 85.2 | 83.2 – 87.4 |
| Control | 84.0 | 81.9 – 86.0 |
Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | 528.7 | ± 155.1 |
| Control | 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.
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | 3.6 | ± 2.2 |
| Control | 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).
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | -0.10 | ± 0.11 |
| Control | -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).
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | -0.09 | ± 0.14 |
| Control | -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).
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | -0.08 | ± 0.11 |
| Control | -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
| Group | Value | 95% CI |
|---|---|---|
| Personal Sound Amplification Products | 3.8 | ± 1.1 |
| Control | 4.2 | ± 0.9 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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