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临床试验/NCT03511417
NCT03511417撤回不适用

Aging and Speech Perception in Complex Listening Environments

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家开始时间: 2018年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Speech Perception

研究概览

简要总结

The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.

详细描述

The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.

研究设计

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

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-64 years
  • Mild to moderate high frequency hearing loss
  • Learned English as a first language

排除标准

  • Previous use of hearing aids
  • Hearing loss/problems attributed to factors other than aging
  • History of: neurologic disorder, middle-ear disease
  • Score of < 26 on the Montreal Cognitive Assessment

结局指标

主要结局

Speech Perception

时间窗: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to understand sentences presented in background noise

Localization Ability

时间窗: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to indicate where a sound is coming from when presented in background noise

Cognitive Load

时间窗: every two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to remember speech that has previously been presented in background noise

Self-Perceived Listening Effort

时间窗: every two weeks until asymptotic performance is noted (up to 12 weeks)

Changes in how difficult it is to understand speech in background noise

次要结局

  • Self-perceived hearing device benefit(daily during field trial (up to 12 weeks))
  • Overall perceived benefit from hearing device(every two weeks until asymptotic performance is noted (up to 12 weeks))

研究者

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

Karen Helfer

Professor and Chair

University of Massachusetts, Amherst

研究点 (2)

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