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临床试验/NCT04513782
NCT04513782招募中不适用

The Contributions of Age Related Changes in the Sound Localization Pathway to Central Hearing Loss

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Speech in Noise Performance

研究概览

简要总结

Age-related hearing loss, presbycusis, affects up to 50% of American adults. There are two main causes for presbycusis: 1) Progressive death of hair cells in the inner ear, and 2) Central hearing loss, or the reduced ability to decipher the sound source of interest from other competing sounds in a multi-source complex environment. The first cause is better understood and treatment options, such as hearing aids and cochlear implants, are available. However, central hearing loss is not as well understood and there is not a treatment available at this time. This study aims to advance our understanding of central hearing loss by evaluating the abilities of younger and older listeners in two primary outcome measures: to 1) neurologically process sound stimuli and 2) focus on conversational speech in the presence of spatially-separated competing background noise. A test using Auditory Brainstem Responses (ABR) will be used to evaluate the brain's response to clicking sounds.

This study will assess all waveform data, but will focus particularly on wave III. Sentence in noise tests will be used to assess each subject's ability to process speech in noisy situations. Both the ABR and sentence in noise tests are non-invasive and are commonly used in audiology practices to diagnosis and treat a variety of audiological pathologies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
40 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age ranges
  • a. 21 years (inclusive) and 89years (inclusive)
  • Subjects exhibiting no poorer than a mild hearing loss, defined as hearing thresholds no worse than 40dBHL at any test frequency 250-4000 Hz based on pure tone audiometry
  • Subjects scoring 26 or higher on a screening measure of cognitive status (Montreal Cognitive Screening Assessment; MoCA)

排除标准

  • Patients outside the age range of 21-89
  • Patients with an air-bone gap greater than 10dBHL at any frequency
  • Patients who are decisionally challenged and/or unable to complete speech perception testing. These patients are excluded based on the study requiring behavioral responses to some tests
  • Patients with little command of the English language who are unable to understand and repeat back simple everyday English sentences.
  • Illiterate patients
  • Patients with neurodegenerative diseases.

结局指标

主要结局

Speech in Noise Performance

时间窗: through study completion, an average of 6 years

Auditory perception task requiring participants to discriminate speech sound in quiet and in back ground noise. Takes about 90min.

Auditory Brainstem Response

时间窗: through study completion, an average of 6 years

Non-invasive auditory electrophysiological measure of brainstem electrical activity captured using electrodes placed on the scalp while sounds are played to one or both ears. Takes about 60min

Spatial Acuity

时间窗: through study completion, an average of 6 years

Auditory perception task requiring participants to judge the location of a sound. Takes about 90min

次要结局

  • Working Memory Assessment(through study completion, an average of 6 years)
  • TFS-AF(through study completion, an average of 6 years)
  • Electrocorticogram(through study completion, an average of 6 years)
  • Subject Questionnaires(through study completion, an average of 6 years)
  • Spectrotemporal Modulation(through study completion, an average of 6 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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