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临床试验/NCT05584514
NCT05584514已完成不适用

Understanding the Effects of Listening Effort on Sentence Processing and Memory in Sensorineural Hearing Loss: Evidence From Simultaneous Electrophysiology and Pupillometry (Study 1)

University of Utah2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
N400

研究概览

简要总结

Sensorineural hearing loss (SNHL) is among the most prevalent chronic conditions in aging and has a profoundly negative effect on speech comprehension, leading to increased social isolation, reduced quality of life, and increased risk for the development of dementia in older adulthood. Typical audiological tests and interventions, which focus on measuring and restoring audibility, do not explain the full range of cognitive difficulties that adults with hearing loss experience in speech comprehension. For example, adults with SNHL have to work disproportionally harder to decode acoustically degraded speech. That additional effort is thought to diminish shared executive and attentional resources for higher-level language processes, impacting subsequent comprehension and memory, even when speech is completely intelligible. This phenomenon has been referred to as listening effort (LE). There is a growing understanding that these cognitive factors are a critical and often "hidden effect" of hearing loss. At the same time, the effects of LE on the neural mechanisms of language processing and memory in SNHL are currently not well understood. In order to develop evidence-based assessments and interventions to improve comprehension and memory in SNHL, it is critical that we elucidate the cognitive and neural mechanisms of LE and its consequences for speech comprehension. In this project, we adopt a multi-method approach, combining methods from clinical audiology, psycholinguistics, and cognitive neuroscience to address this gap of knowledge. Specifically, we adopt a novel and innovative method of co-registering pupillometry (a reliable physiological measure of LE) and language-related event-related brain potential (ERP) measures during real-time speech processing to characterize the effects of acoustic challenge and LE on high-level language processes (e.g., semantic retrieval, syntactic integration) and subsequent speech memory in older adults with SNHL. This innovative work addresses a time-sensitive gap in the literature regarding the identification of objective and reliable markers of specific neurocognitive processes impacted by acoustic challenge and LE in age-related SNHL.

详细描述

This experiment is a BESH (Basic Experimental Study with Humans) Trial. All participants are exposed to all experimental conditions (i.e., "interventions") in a complete factorial 2 x 3 within-subjects experimental design. Participants will consist of 80 older adults between the ages of 60 - 90 who will be recruited from the Salt Lake metro community. Participants will be recruited through the Utah Senior Ears database, the Utah Center on Aging, through flyers placed throughout the community (e.g., bulletin boards, waiting area in the ENT clinic at the University of Utah), through on-line advertisements (e.g., Facebook) and via word-of-mouth. Participants will be compensated with financial incentives. The investigators will recruit for an approximately equal number of participants into two hearing groups based on their pure-tone average (PTA) thresholds: normal hearing (PTA of < 25 dBHL, 1-4kHz) and clinically-relevant hearing loss (PTA of > 25 dBHL 1-4kHz). While the investigators adopt this dichotomous grouping for recruitment, hearing level will be treated as as continuous to increase statistical power.

The investigators will follow all APA guidelines with respect to the treatment of human subjects. All participants will provide informed consent after study procedures are explained to them and the voluntary nature of participation will be emphasized. No identifying information (e.g., names) will be obtained from participants and the only information connected to their data files will be a unique, arbitrary code.

Study procedures will be conducted within a single session, lasting between 3-4 hours. Following informed consent, participants will complete a standardized hearing assessment, neuropsychological assessment, audibility control assessment, and then participant in the EEG/pupillometry experiment, each of which is described below. All data will be stored on password-protected computers in the PI's laboratory. All material from participants will be collected specifically for research purposes. The only identifying information that is collected about subjects is their names, which will be used to recruit and compensate participants, but will not be linked to their data in any way. The materials presented in these studies have no known potential to stress, embarrass, stigmatize, or incriminate experimental participants.

Prior to the beginning of the experiment, two audiometric tests will be conducted via an MA-41 audiometer via RadioEar IP-30 insert air-conduction earphones. First, pure-tone thresholds will be measured using the modified Hughson- Westlake at octave frequencies from 250 to 8000 Hz for each ear. Second, speech recognition thresholds (SRTs) will be measured using a recorded Central Institute for the Deaf (CID) W-1 spondee word list Near visual acuity was also tested for both the right and left eye using the Rosenbaum visual acuity test.

Participants will then complete a brief battery of cognitive assessments. (a) the Montreal Cognitive Assessment (MoCA). Although the appropriate cut-off score for cognitive impairment in the MoCA is variable across samples, individuals scoring below 20 are generally considered to be at increased risk for MCI. Participants will also complete the F-A-S phonemic fluency task as a measure of verbal fluency, via the short- form computerized version of the reading span task as a measure of verbal working memory, and the extended range vocabulary tests from the ETS Kit of Factor Referenced Cognitive Tests, as a measure of verbal ability. Participants will then complete an audibility control task. For this task, the same native speaker of American English will be used to record the stimuli at the same +3dB. Participants will hear nine different test sentences (e.g., "Don't touch the wet paint) and will be tasked with "shadowing" each sentence by repeating out loud each word as it was heard. The immediate repetition is done to reduce the contribution of any memory components to task performance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

No masking -- participants are presented various stimuli in different experimental conditions.

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

入选标准

  • Age 60-90; right-handed; native English speaker; scores in the normal range (< 25 points) on Montreal Cognitive Assessment (MoCA); for adults with hearing loss, a pure-tone average score of > 25 dB HL (between 1 - 4kHz)

排除标准

  • left-handed (language-related electrophysiological responses of left-handed subjects differ from those of right-handed subjects); history of psychiatric or neurological illnesses (including skull fractures, as this is known to alter electrophysiological response at the scalp); score of > 25 points on the MOCA; use of certain prescription and non-prescription drugs known to alter brain function and the autonomic nervous system, including pupil dilation (e.g., anti-depressants, ADHD drugs); any eye disease that would impair the ability to measure pupil dilation (e.g., cataracts, nystagmus, amblyopia); scores on speech shadowing audibility control task below 50%, suggesting poor intelligibility; a display of behavior that would significantly interfere with the validity of data collection or safety during the study;

结局指标

主要结局

N400

时间窗: 1 day

The N400 mean amplitude and latency will be measured from the ERP waveform for each condition, using standard procedures for ERP research.

P600

时间窗: 1 day

The P600 mean amplitude and latency will be measured from the ERP waveform for each condition, using standard procedures.

Pupil Dilation

时间窗: 1 day

The pupil dilation response (average proportion change from baseline) will be measured from the continuous pupillometry time series, measured prior to target word onset, and compared between speech samples presented in quiet and in noise.

Delayed Recognition Memory

时间窗: 1 day

Recognition memory will be measured using both standard accuracy and signal detection measures from the recognition memory task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brennan R Payne

Assistant Professor of Psychology

University of Utah

研究点 (2)

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