Effects of PSAPs on Speech Processing

Sponsor
Rotman Research Institute at Baycrest (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076045
Collaborator
(none)
100
1
2
18
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Personal sound amplification products
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Immediate Effects of Personal Sound Amplification Products on Speech Processing
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Difference in EEG measure of wave amplitude with and without PSAPs [6 hours]

    Difference in EEG wave amplitude (in μV) in the speech-in-noise task when using PSAPs and when using no device.

  2. Difference in EEG measure of wave latency with and without PSAPs [6 hours]

    Difference in EEG wave latency (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.

  3. Difference in EEG measure of wave oscillations with and without PSAPs [6 hours]

    Difference in EEG wave time-frequency oscillations in the speech-in-noise task when using PSAPs and when using no device.

  4. Difference in EEG measure of connectivity strength with and without PSAPs [6 hours]

    Difference in connectivity strength in the speech-in-noise task when using PSAPs and when using no device.

  5. Difference in the percentage of correct responses with and without PSAPs [6 hours]

    Difference in the percentage (%) of correct responses in the speech-in-noise task when using PSAPs and when using no device.

  6. Difference in reaction time with and without PSAPs [6 hours]

    Difference in reaction time (in milliseconds) in the speech-in-noise task when using PSAPs and when using no device.

  7. Difference in sensitivity with and without PSAPs [6 hours]

    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.

  8. Difference in criterion with and without PSAPs [6 hours]

    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

  1. Difference in cognitive inhibition with and without PSAPs [6 hours]

    Difference in interference effect in the auditory version of the Stroop task when using PSAPs and when using no device.

  2. Difference in self-reported measure of listening effort with and without PSAPs [6 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Mild to moderate hearing loss (i.e. hearing thresholds between 25 dB and 60 dB)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rotman Research Institute at Baycrest Centre Toronto Ontario Canada M6A 2E1

Sponsors and Collaborators

  • Rotman Research Institute at Baycrest

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Claude Alain, Senior Scientist, Rotman Research Institute at Baycrest
ClinicalTrials.gov Identifier:
NCT05076045
Other Study ID Numbers:
  • PSAPs2021
First Posted:
Oct 13, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Claude Alain, Senior Scientist, Rotman Research Institute at Baycrest
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022