Effects of PSAPs on Speech Processing

Study Overview
=================
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.

Official Title
-----------------
Immediate Effects of Personal Sound Amplification Products on Speech Processing

Conditions
-----------------
Hearing Loss, Age-Related

Intervention / Treatment
-----------------
* Device: Personal sound amplification products


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personal sound amplification products<br>Speech perception will be evaluated using personal sound amplification products. | Device: Personal sound amplification products<br>* Participants will be tested with bilateral personal sound amplification products.<br>|
| No Intervention: Control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing loss, Speech processing, Speech-in-noise, Aging