Clinical trial NCT05076045: Effects of PSAPs on Speech Processing
Official title: Immediate Effects of Personal Sound Amplification Products on Speech Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Age-Related
Keywords: Hearing loss
Speech processing
Speech-in-noise
Aging
Lead sponsor: Rotman Research Institute at Baycrest
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Percentage of Correct Responses With and Without PSAPs
timeFrame: 1 hour
measure: Reaction Time With and Without PSAPs
timeFrame: 1 hour
measure: Quick Speech In Noise Score With and Without PSAPs
timeFrame: 1 hour
measure: Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs
timeFrame: 1 hour
measure: Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs
timeFrame: 1 hour
measure: Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs
timeFrame: 1 hour
Secondary outcomes:
measure: Self-reported Measure of Listening Effort With and Without PSAPs
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Rotman Research Institute at Baycrest Centre
state: Ontario
Study officials:
affiliation: Rotman Research Institute at Baycrest Centre
name: Claude Alain, PhD
role: PRINCIPAL_INVESTIGATOR
References: