Hearing Loss, Age-RelatedNCT05076045

Effects of PSAPs on Speech Processing

A study testing Personal sound amplification products in people with Hearing Loss, Age-Related, run by Rotman Research Institute at Baycrest at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 90 years
Conditions the study is for: Hearing Loss, Age-Related
What is being tested?: Personal sound amplification products
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: 1 Mar 2022to 1 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Right-handed

Who cannot join

Mother tongue not English
Language impairment
Dementia
Cerebrovascular diseases
Untreated vision impairment;
Tinnitus and otologic disorders

Show all 11Show fewer

Cochlear implant
History of prior hearing aid use
Diagnosed addiction (alcohol or drugs)
Significant medical or neurocognitive conditions or interventions likely to significantly impact cognitive function (e.g., epilepsy, stroke, traumatic brain injury with loss of consciousness > 5 minutes, brain tumor, multiple sclerosis, hepatitis C, developmental delay, electroconvulsive therapy)
a diagnosis (based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)) of major depressive disorder with active symptoms within 90 days of study entry, past or present psychosis, or other psychiatric disorders such as obsessive-compulsive disorder, generalized anxiety disorder, and bipolar disorder

Trial locations and contacts

1 site in 1 country.

Canada1 site

Rotman Research Institute at Baycrest Centre
Toronto, Ontario, M6A 2E1

Other trials in Canada

About this study

Official title: Immediate Effects of Personal Sound Amplification Products on Speech Processing

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.

Read the detailed description

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.

Conditions: Hearing Loss, Age-Related
Being tested: Personal sound amplification products
Keywords: Hearing loss, Speech processing, Speech-in-noise, Aging
Medical subject headings: Presbycusis, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personal sound amplification productsDevice
Participants will be tested with bilateral personal sound amplification products.

Study groups in NCT05076045
Study group	Role	What they receive
Personal sound amplification products	Experimental	Speech perception will be evaluated using personal sound amplification products. Receives: Device: Personal sound amplification products
Control	No intervention	Speech perception will be evaluated without using hearing devices.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 hour

Secondary outcomes (1)

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.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20221 Oct 2022

First posted13 Oct 2021
Study start1 Mar 2022
Primary completion1 Oct 2022
Study completion1 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05076045
Sponsor's protocol ID: PSAPs2021
Status last verified: Nov 2024
First submitted: 20 Sep 2021
Last updated: 5 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

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.
PubMed 40910451
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.
PubMed 37467243

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
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Hearing Healthcare Assessment in Rural Communities
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All Hearing Loss, Age-Related trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate Effects of Personal Sound Amplification Products on Speech Processing
ClinicalTrials.gov ID: NCT05076045
Acronym / sponsor ID: PSAPs2021
Conditions: Hearing Loss, Age-Related
Keywords: Hearing loss, Speech processing, Speech-in-noise, Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Rotman Research Institute at BaycrestUniversity, hospital or other
Study start: 1 Mar 2022 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 1 Oct 2022 (actual)
First posted: 13 Oct 2021 (actual)
Results: Posted 5 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Personal sound amplification products	Experimental	Device: Personal sound amplification productsSpeech perception will be evaluated using personal sound amplification products.
Control	No intervention	–Speech perception will be evaluated without using hearing devices.

Who may qualify

Ages: 60 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Right-handed

Key exclusion criteria (11 listed)

Mother tongue not English
Language impairment
Dementia
Cerebrovascular diseases
Untreated vision impairment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Personal sound amplification productsParticipants will be tested with bilateral personal sound amplification products.	Device	Personal sound amplification products

Primary outcome

Percentage of Correct Responses With and Without PSAPs
Time frame: 1 hour
Percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
Reaction Time With and Without PSAPs
Time frame: 1 hour
Reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
Quick Speech In Noise Score With and Without PSAPs
Time frame: 1 hour
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.
Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs
Time frame: 1 hour
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).
Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs
Time frame: 1 hour
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).
Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs
Time frame: 1 hour
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 secondary outcome

Self-reported Measure of Listening Effort With and Without PSAPs
Time frame: 1 hour

Results and safety

Results posted to the registry on 5 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Personal Sound Amplification Products First, Then Control	16	16
Control First, Then Personal Sound Amplification Products	16	16

Primary outcome: Percentage of Correct Responses With and Without PSAPs

Time frame: 1 hour. Mean (95% Confidence Interval). Unit: percentage of correct answers

Measure	Personal Sound Amplification Products n = 28	Control n = 28
Value	85.2 (83.2 to 87.4)	84.0 (81.9 to 86.0)

Personal Sound Amplification Products vs Control: p = 0.03, Mixed Models Analysis

Population analysed: All participants who completed all study visits were included in the analysis.

Primary outcome: Reaction Time With and Without PSAPs

Time frame: 1 hour. Mean (Standard Deviation). Unit: milliseconds

Measure	Personal Sound Amplification Products n = 26	Control n = 26
Value	528.7 (155.1)	502.0 (145.9)

Personal Sound Amplification Products vs Control: p = 0.28, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Quick Speech In Noise Score With and Without PSAPs

Time frame: 1 hour. Mean (Standard Deviation). Unit: dB

Measure	Personal Sound Amplification Products n = 28	Control n = 28
Value	3.6 (2.2)	4.6 (2.4)

Personal Sound Amplification Products vs Control: p = 0.005, Wilcoxon (Mann-Whitney)

Population analysed: All participants who completed all study visits were included in the analysis.

Primary outcome: Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs

Time frame: 1 hour. Mean (Standard Deviation). Unit: percentage of power change

Measure	Personal Sound Amplification Products n = 25	Control n = 25
Value	-0.10 (0.11)	-0.12 (0.12)

Personal Sound Amplification Products vs Control: p = 1.00, Mixed Models Analysis

Population analysed: One participant did not complete the EEG portion of the study. Two other participants were excluded due to noisy data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the first and second sessions, over a period of approximately one week.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Personal Sound Amplification Products	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Control	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40910451Perron 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.
Derived from this study: PubMed 37467243Perron 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.
Individual participant dataSharing planned: 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.

Related trials for Hearing Loss, Age-Related

Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing Loss, Presbyacusis
Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claude Alain, PhD principal investigator

Rotman Research Institute at Baycrest Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Personal sound amplification products in people with Hearing Loss, Age-Related, run by Rotman Research Institute at Baycrest at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Correct Responses With and Without PSAPs (time frame: 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076045, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.