Effects of PSAPs on Speech Processing

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Age-Related
• Intervention / Treatment: Device: Personal sound amplification products

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personal sound amplification products; Speech perception will be evaluated using personal sound amplification products.	Device: Personal sound amplification products; Participants will be tested with bilateral personal sound amplification products.
No Intervention: Control; Speech perception will be evaluated without using hearing devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in EEG measure of wave amplitude with and without PSAPs	Difference in EEG wave amplitude (in μV) in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in EEG measure of wave latency with and without PSAPs	Difference in EEG wave latency (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in EEG measure of wave oscillations with and without PSAPs	Difference in EEG wave time-frequency oscillations in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in EEG measure of connectivity strength with and without PSAPs	Difference in connectivity strength in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in the percentage of correct responses with and without PSAPs	Difference in the percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in reaction time with and without PSAPs	Difference in reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.	6 hours
Difference in sensitivity with and without PSAPs	Difference in sensitivity in the speech-in-noise task when using PSAPs and when using no device. Sensitivity is a measure of the ability to correctly recognize whether pairs are different or not.	6 hours
Difference in criterion with and without PSAPs	Difference in criterion in the speech-in-noise task when using PSAPs and when using no device. The criterion is a measure of response bias that measures the tendency to choose one response over another.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in self-reported measure of listening effort with and without PSAPs	Difference in self-reported listening effort in the speech-in-noise task when using PSAPs and when using no device. Listening effort is measured on a 7-point scale.	6 hours

Collaborators and Investigators

• Sponsor: Rotman Research Institute at Baycrest
• Investigators: Principal Investigator: Claude Alain, PhD, Rotman Research Institute at Baycrest Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Aging; Hearing loss; Speech-in-noise; Speech processing
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: PSAPs2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be shared when the article is published and will remain accessible as long as possible.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No