Effects of PSAPs on Speech Processing

NCT05076045 | Completed Results

• 1 other identifier: PSAPs2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss, Age-Related

Keywords

Hearing loss; Speech processing; Speech-in-noise; Aging

Outcome Measures

Primary Outcomes (6)

• 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).

  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

Secondary Outcomes (1)

• Self-reported Measure of Listening Effort With and Without PSAPs

  1 hour

Study Arms (2)

Personal sound amplification products

EXPERIMENTAL

Speech perception will be evaluated using personal sound amplification products.

Device: Personal sound amplification products

Control

NO INTERVENTION

Speech perception will be evaluated without using hearing devices.

Interventions

Personal sound amplification products DEVICE

Participants will be tested with bilateral personal sound amplification products.

Personal sound amplification products

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-handed

You may not qualify if:

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

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: lead

Study Sites (1)

Rotman Research Institute at Baycrest Centre

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (2)

• 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.

  PMID: 40910451 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.

  PMID: 37467243 DERIVED

MeSH Terms

Conditions

Presbycusis; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Claude Alain
• Organization: Baycrest Academy for Research & Education

calain@research.baycrest.org

416-785-2500

Study Officials

• Claude Alain, PhD

  Rotman Research Institute at Baycrest Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 13, 2021
• Study Start: March 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

CA (1)