跳至主要内容
临床试验/NCT05145946
NCT05145946撤回不适用

Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds

Massachusetts Eye and Ear Infirmary0 个研究点目标入组 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
撤回
入组人数
80
主要终点
Change in Speech Recognition in Noise Performance Accuracy

研究概览

简要总结

Difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. This complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. In this study, an immersive audiomotor training game will be utilized to drive improvements in speech intelligibility, controlled by an auditory memory training game. Physiological measures will be tracked that could inform clinical assessment of hearing in noise abilities.

详细描述

Hearing loss is a chronic health disorder affecting approximately 15 percent of Americans. High-frequency hearing loss can be imperceptible when listening in quiet environments. However, in complex noisy environments, individuals can severely suffer from an inability to resolve speech. This is despite having normal audiometric thresholds in the low-frequency range within which speech signals are contained. There are several factors that could contribute to speech intelligibility difficulties that are imperceptible with typical hearing tests. These include impaired temporal encoding at the auditory nerve and the downstream sequelae of peripheral damage in the central auditory pathway. The goal of this study is to assess how a set of physiological measures of auditory/neural processing map onto suprathreshold hearing outcomes.

In a previous study, significant improvements in speech intelligibility have resulted from training on an immersive video game. The game uses a closed-loop audiomotor interface design that reinforces sensory-guided feedback. As a control, an auditory memory training game has been developed to replicate user expectations and procedural learning. In this study, an audiomotor game and control game will be used as mechanisms through which to track changes to physiological and perceptual biomarkers in a high frequency hearing loss cohort and a matched normal hearing cohort. Tests will be run pre-training, post- training, and at a follow-up point.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • High frequency hearing loss subjects - Thresholds of 15 dB HL or less for 0.25-2 kHz. Thresholds of 30-60 dB HL from 3-8 kHz.
  • Normal hearing subjects - Thresholds of 15 dB HL or less from 0.5-8 kHz.
  • Thresholds between left and right ears symmetric within 10 dB for all frequencies.
  • Native English speakers.

排除标准

  • Conductive hearing loss (as assessed by audiologist).
  • Active otologic disease (as assessed by audiologist).
  • Significant cognitive decline (Montreal Cognitive Assessment score > 25).

结局指标

主要结局

Change in Speech Recognition in Noise Performance Accuracy

时间窗: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)

Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.

次要结局

  • Change in the neural encoding fidelity for frequency modulated tones(Pre-test / Post-test (8 weeks) / Follow-up (16 weeks))
  • Change in the psychophysical frequency modulation detection threshold(Pre-test / Post-test (8 weeks) / Follow-up (16 weeks))
  • Increase in pupil dilation while listening to sentences in noise(Pre-test / Post-test (8 weeks) / Follow-up (16 weeks))

研究者

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

Daniel Brandon Polley

Daniel Polley, Professor in Department of Otology and Laryngology, Massachusetts Eye and Ear Infirmary

Massachusetts Eye and Ear Infirmary

相似试验