N/A N=32 Randomized Basic Science

Effects of PSAPs on Speech Processing

Hearing Loss, Age-Related

Bottom Line

View on ClinicalTrials.gov: NCT05076045 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Percentage of Correct Responses With and Without PSAPs — 85.2; 84.0 percentage of correct answers — p=0.03

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Personal sound amplification products (Device)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Rotman Research Institute at Baycrest
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Correct Responses With and Without PSAPs	85.2; 84.0	0.03 sig
PRIMARY Reaction Time With and Without PSAPs	528.7; 502.0	0.28
PRIMARY Quick Speech In Noise Score With and Without PSAPs	3.6; 4.6	0.005 sig
PRIMARY Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs	-0.10; -0.12	1.00
PRIMARY Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs	-0.09; -0.08	1.00
PRIMARY Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs	-0.08; -0.01	0.36
SECONDARY Self-reported Measure of Listening Effort With and Without PSAPs	3.8; 4.2	<0.001 sig

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.

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

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Data sourced from ClinicalTrials.gov (NCT05076045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.