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Effects of PSAPs on Speech Processing

R

Rotman Research Institute at Baycrest

Status

Completed

Conditions

Hearing Loss, Age-Related

Treatments

Device: Personal sound amplification products

Study type

Interventional

Funder types

Other

Identifiers

NCT05076045
PSAPs2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

60 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Personal sound amplification products
Experimental group
Description:
Speech perception will be evaluated using personal sound amplification products.
Treatment:
Device: Personal sound amplification products
Control
No Intervention group
Description:
Speech perception will be evaluated without using hearing devices.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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