Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal sound amplification products | Experimental | Speech perception will be evaluated using personal sound amplification products. |
|
| Control | No Intervention | Speech perception will be evaluated without using hearing devices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal sound amplification products | Device | Participants will be tested with bilateral personal sound amplification products. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claude Alain, PhD | Rotman Research Institute at Baycrest Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rotman Research Institute at Baycrest Centre | Toronto | Ontario | M6A 2E1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40910451 | Derived | Perron M, Dimitrijevic A, Alain C. Rapid Brain Adaptation to Hearing Amplification: A Randomized Crossover Trial of Personal Sound Amplification Products. Trends Hear. 2025 Jan-Dec;29:23312165251375891. doi: 10.1177/23312165251375891. Epub 2025 Sep 5. | |
| 37467243 | Derived | Perron M, Lau B, Alain C. Interindividual variability in the benefits of personal sound amplification products on speech perception in noise: A randomized cross-over clinical trial. PLoS One. 2023 Jul 19;18(7):e0288434. doi: 10.1371/journal.pone.0288434. eCollection 2023. |
Not provided
Not provided
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.
The data will be shared when the article is published and will remain accessible as long as possible.
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.
Not provided
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.
72 participants were screened for eligibility between March 1, 2022 and September 31, 2022 by telephone interview at Baycrest Hospital in Toronto, Canada.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Hours) |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Second Intervention (3 Hours) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completed all study visits were included in the analysis. | Posted | Mean | 95% Confidence Interval | percentage of correct answers | 1 hour |
|
Adverse events were collected during the first and second sessions, over a period of approximately one week.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personal Sound Amplification Products | Participants were tested for speech-in-noise perception while using bilateral personal sound amplification products. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claude Alain | Baycrest Academy for Research & Education | 416-785-2500 | 3523 | calain@research.baycrest.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2022 | Apr 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Apr 1, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011304 | Presbycusis |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | 1 hour |
| 1 hour |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Reaction Time With and Without PSAPs | Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device. | 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. | Posted | Mean | Standard Deviation | milliseconds | 1 hour |
|
|
|
|
| Primary | 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. | All participants who completed all study visits were included in the analysis. | Posted | Mean | Standard Deviation | dB | 1 hour |
|
|
|
|
| Primary | 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). | One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data. | Posted | Mean | Standard Deviation | percentage of power change | 1 hour |
|
|
|
|
| Primary | 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). | One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data. | Posted | Mean | Standard Deviation | percentage of power change | 1 hour |
|
|
|
|
| Primary | 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). | One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data. | Posted | Mean | Standard Deviation | percentage of power change | 1 hour |
|
|
|
|
| Secondary | 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. | All participants who completed all study visits were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 hour |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Control | Participants were tested for speech perception in noise while using no devices. | 0 | 28 | 0 | 28 | 0 | 28 |
Not provided
Not provided
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |