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Effects of PSAPs on Speech Processing

Primary Purpose

Hearing Loss, Age-Related

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Personal sound amplification products
Sponsored by
Rotman Research Institute at Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss, Age-Related focused on measuring Hearing loss, Speech processing, Speech-in-noise, Aging

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rotman Research Institute at Baycrest Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personal sound amplification products

Control

Arm Description

Speech perception will be evaluated using personal sound amplification products.

Speech perception will be evaluated without using hearing devices.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 20, 2021
Last Updated
November 22, 2022
Sponsor
Rotman Research Institute at Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT05076045
Brief Title
Effects of PSAPs on Speech Processing
Official Title
Immediate Effects of Personal Sound Amplification Products on Speech Processing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rotman Research Institute at Baycrest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Age-Related
Keywords
Hearing loss, Speech processing, Speech-in-noise, Aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal sound amplification products
Arm Type
Experimental
Arm Description
Speech perception will be evaluated using personal sound amplification products.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Speech perception will be evaluated without using hearing devices.
Intervention Type
Device
Intervention Name(s)
Personal sound amplification products
Intervention Description
Participants will be tested with bilateral personal sound amplification products.
Primary Outcome Measure Information:
Title
Difference in EEG measure of wave amplitude with and without PSAPs
Description
Difference in EEG wave amplitude (in μV) in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in EEG measure of wave latency with and without PSAPs
Description
Difference in EEG wave latency (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in EEG measure of wave oscillations with and without PSAPs
Description
Difference in EEG wave time-frequency oscillations in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in EEG measure of connectivity strength with and without PSAPs
Description
Difference in connectivity strength in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in the percentage of correct responses with and without PSAPs
Description
Difference in the percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in reaction time with and without PSAPs
Description
Difference in reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.
Time Frame
6 hours
Title
Difference in sensitivity with and without PSAPs
Description
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.
Time Frame
6 hours
Title
Difference in criterion with and without PSAPs
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Difference in self-reported measure of listening effort with and without PSAPs
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Alain, PhD
Organizational Affiliation
Rotman Research Institute at Baycrest Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rotman Research Institute at Baycrest Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Effects of PSAPs on Speech Processing

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