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临床试验/NCT05076045
NCT05076045已完成不适用

Immediate Effects of Personal Sound Amplification Products on Speech Processing

Rotman Research Institute at Baycrest1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Percentage of Correct Responses With and Without PSAPs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Right-handed

排除标准

  • •Mother tongue not English
  • •Language impairment
  • •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

研究组 & 干预措施

Personal sound amplification products

Experimental

Speech perception will be evaluated using personal sound amplification products.

干预措施: Personal sound amplification products (Device)

Control

No Intervention

Speech perception will be evaluated without using hearing devices.

结局指标

主要结局

Percentage of Correct Responses With and Without PSAPs

时间窗: 1 hour

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

Reaction Time With and Without PSAPs

时间窗: 1 hour

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

Quick Speech In Noise Score With and Without PSAPs

时间窗: 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.

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

时间窗: 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).

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

时间窗: 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).

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

时间窗: 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).

次要结局

  • Self-reported Measure of Listening Effort With and Without PSAPs(1 hour)

研究者

发起方
Rotman Research Institute at Baycrest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claude Alain

Senior Scientist

Rotman Research Institute at Baycrest

研究点 (1)

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