Effects of PSAPs on Speech Processing

NCT ID: NCT05076045

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-10-01

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Personal sound amplification products

Speech perception will be evaluated using personal sound amplification products.

Group Type: EXPERIMENTAL

Personal sound amplification products

Intervention Type: DEVICE

Participants will be tested with bilateral personal sound amplification products.

Control

Speech perception will be evaluated without using hearing devices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personal sound amplification products

Participants will be tested with bilateral personal sound amplification products.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Right-handed

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rotman Research Institute at Baycrest

OTHER

Sponsor Role: lead

Responsible Party

Claude Alain

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claude Alain, PhD

Role: PRINCIPAL_INVESTIGATOR

Rotman Research Institute at Baycrest Centre

Locations

Rotman Research Institute at Baycrest Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40910451 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37467243 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PSAPs2021

Identifier Type: -

Identifier Source: org_study_id