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Completed

NCT Number: NCT05076045

Effects of PSAPs on Speech Processing

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.

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Key information

Conditions

Hearing Loss, Age-Related Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rotman Research Institute at Baycrest Centre

Toronto, Ontario, M6A 2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal sound amplification products

Device

Participants will be tested with bilateral personal sound amplification products.

Primary outcomes

  1. Percentage of Correct Responses With and Without PSAPs

    Time frame: 1 hour

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

  2. Reaction Time With and Without PSAPs

    Time frame: 1 hour

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

  3. Quick Speech In Noise Score With and Without PSAPs

    Time frame: 1 hour

    Performance on the QuickSIN when using PSAPs and when using no device. The QuickSIN measures the signal-to-noise ratio loss. A high score indicates poorer speech understanding in noise.

  4. Alpha Power (8-12 Hz) During the Processing of the First Word in a Low Noise Condition, With and Without PSAPs

    Time frame: 1 hour

    Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a low noise condition (signal-to-noise ratio of +3 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).

  5. Alpha Power (8-12 Hz) During the Processing of the First Word in a Medium Noise Condition, With and Without PSAPs

    Time frame: 1 hour

    Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a medium noise condition (signal-to-noise ratio of 0 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).

  6. Alpha Power (8-12 Hz) During the Processing of the First Word in a High Noise Condition, With and Without PSAPs

    Time frame: 1 hour

    Alpha power (8-12 Hz) for a cluster of temporoparietal electrodes (T7, TP7, CP5), measured between 50 and 500 ms after the onset of the first word of the speech-in-noise task, under a high noise condition (signal-to-noise ratio of -3 dB), with and without PSAPs. Alpha power was measured using temporal spectral evolution analysis with EEG. Values are baseline corrected with the pre-stimulus interval period (-500, 0 ms). Higher values indicate greater alpha power compared to the pre-stimulus interval period (i.e., event-related synchronization).

Secondary outcomes

  1. Self-reported Measure of Listening Effort With and Without PSAPs

    Time frame: 1 hour

    Self-reported listening effort in the speech-in-noise task when using PSAPs and when using no device. Participants used a seven-point Likert scale to rate the listening effort required to complete the speech-in-noise task. The specific question was: "Using the scale in front of you, can you estimate how much effort it took you to understand the words in the presence of background noise? If you think that the amount of effort was between two numbers on the scale, it is fine for you to pick a fraction," with number 1 corresponding to "No effort" and number 7 corresponding to "Extreme effort." A high score indicates a greater listening effort.

Sponsors and collaborators

Lead sponsor

Rotman Research Institute at Baycrest

Other

Registry information

Official study title

Immediate Effects of Personal Sound Amplification Products on Speech Processing

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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