跳至主要内容
临床试验/NCT02574247
NCT02574247终止不适用

Role of the Auditory Efferent System in Auditory Perceptual Learning

VA Loma Linda Health Care System2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
28
试验地点
2
主要终点
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks

研究概览

简要总结

The purpose of this study is to determine how changes in speech perception resulting from a computerized auditory training program are related to concurrent changes in auditory brainstem function resulting from the training. It is hypothesized that the degree of improvement in speech perception will be correlated with the degree of change in brainstem function.

详细描述

The goal of this study is to determine the impact of an auditory training program on the function of the inner ear and auditory brainstem. In normal-hearing individuals, the medial olivocochlear (MOC) branch of the auditory efferent system appears to aid with hearing signals in noise. A previous study in young normal-hearing adults found that auditory training strengthened the function of the MOC system in some participants in a way that coincided with their improvements in perceiving speech sounds in background noise. The MOC function measured at baseline also predicted the amount of success from the auditory training. Although these results are promising, it is not known if they generalize to populations that often have hearing-in-noise problems such as older and hearing-impaired adults.

This study will examine how an auditory training program impacts MOC activity in a group of older adults with normal hearing or mild hearing loss. This is a prospective study utilizing a repeated-measures design. Participants will participate in a computerized auditory training program taking place over 15 weeks. Transient-evoked otoacoustic emissions (TEOAEs) will be used to measure the strength of MOC activity at each visit. Performance on untrained stimuli (words and sentences) will also be measured. A control group (no auditory training) will also be used to establish test-retest reliability for TEOAE measurements and performance on the word and sentence testing. The results of this study may contribute to the improved diagnosis and treatment of hearing-in-noise problems in Veterans and in the civilian population.

This is a single-site study that will take place at the Auditory Research Laboratory, located at the VA Loma Linda Healthcare System (VALLHS) in Loma Linda, California. Veterans and non-Veterans, both males and females, between the ages of 35 and 89 with either normal hearing or mild sensorineural hearing loss will participate. Women and minorities will be encouraged to participate. Up to 200 volunteers will be enrolled in the study. Each eligible participant will participate in a maximum of 14 study visits.

Participants will be randomly assigned a priori to either the experimental group (auditory training) or Control group (no auditory training) using simple random assignment. Because this study will detect whether or not significant changes in MOC activity and speech perception across time occurred as a result of auditory training, the Control group is needed to establish the test-retest reliability of our outcome measures in the absence of any training.

Preliminary analyses of the data showed an association between a measure of speech perception and the strength of the efferent system. To increase statistical power in examination of this association, an additional group (Speech Group) is incorporated that includes subjects that only participate in one session, with only the measurements of speech recognition and medial olivocochlear reflex activity. The Speech Group will be assigned by the investigators.

研究设计

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

入排标准

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

入选标准

  • 3-frequency pure-tone average ≤40 decibels hearing level (dB HL)
  • Air-bone gaps ≤10 decibels (dB) from 500-4000 Hz
  • 226-Hz tympanograms within normal limits
  • Measurable acoustic reflexes bilaterally
  • Measurable transient-evoked otoacoustic emissions
  • Ability to read and speak English
  • Ability to comply with all test procedures
  • Ability to commute to VA Loma Linda Healthcare System 12 times

排除标准

  • Hearing asymmetry >15 decibels at three or more audiometric frequencies
  • Conductive hearing loss or otologic pathology
  • History of middle ear surgery
  • Chronic disease and/or use of medication that affects ability to participate in test procedures during study period

研究组 & 干预措施

Training

Experimental

Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time.

干预措施: Computerized auditory training (Procedure)

Control

No Intervention

Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.

Speech Group

No Intervention

Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.

结局指标

主要结局

Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks

时间窗: Baseline (First study visit - 3 hour session)

Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and performance (in percent correct) on Coordinate Response Measure (CRM) task and Institute of Electrical and Electronics Engineers (IEEE) sentences, each presented at two decibel signal-to-noise ratios (dB SNR). Results obtained at first study visit.

Change in Magnitude of Medial Olivocochlear Reflex Inhibition

时间窗: First and last measurements (baseline and last session up to a year later)

Decibel difference in medial olivocochlear reflex inhibition computed between final visit and baseline visit, where medial olivocochlear reflex inhibition is quantified as amplitude difference (in decibels) between transient-evoked otoacoustic emissions obtained with versus without broadband noise presented to the contralateral ear.

次要结局

  • Change in Auditory Training Sentence Task Performance(First and last measurements (baseline and last session up to a year later))
  • Change in Auditory Training Phoneme Task Performance(First and last measurements (baseline and last session up to a year later))

研究者

发起方
VA Loma Linda Health Care System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Ian B. Mertes, PhD, AuD

Principal Investigator

VA Loma Linda Health Care System

研究点 (2)

Loading locations...

相似试验