Effects of PSAPs on Speech Processing

Hearing Loss, Age-Related Clinical Trial

Official title:

Immediate Effects of Personal Sound Amplification Products on Speech Processing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076045
• Other study ID #: PSAPs2021
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: Rotman Research Institute at Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Age-Related
• Presbycusis

Intervention

Device:
• Personal sound amplification products
Participants will be tested with bilateral personal sound amplification products.

Locations

Country	Name	City	State
Canada	Rotman Research Institute at Baycrest Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Rotman Research Institute at Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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