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临床试验/NCT01950013
NCT01950013已完成不适用

At-home Auditory Training Clinical Trial

Indiana University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change in Connected Speech Test (CST) Score

研究概览

简要总结

The purpose of this study is to investigate the effectiveness of an auditory training program used at home with the subject's own hearing aids.

详细描述

The most common communication complaint of older adults with impaired hearing is that they can hear speech, but can't understand it. This is especially true where there are competing sounds in the background. Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. All testing for the screening, baseline speech testing, training system orientation, and the outcomes portions of this project will be conducted in the Audiology Research Laboratory (ARL) of the Speech and Hearing Center located at 200 South Jordan Avenue. The use of the training program will be done at the subject's home.

Subjects will first come to the ARL for either one session for a hearing aid follow-up and instruction in the use of the training system (Session 1) or for one session for an initial screening to determine eligibility (Screening) followed then by Session 1. Subjects will then take home a training system that includes a tablet computer that has the training program loaded onto it, a portable loudspeaker, and some accessories. There will be three groups of subjects: (1) Hearing aid alone--no training (passive control); (2) Hearing aid plus auditory training (training); and (3) Hearing aid plus audio book use (active control). Total enrollment will be 45 subjects. Those subjects in the training group and active control group will complete a 6-week training period and return to the lab for outcome measures after 6 weeks of training for the primary and secondary outcome measures. The hearing aid alone group will return for the same outcome measures as the training and active control groups, but will have no intervention between these follow-up sessions.

研究设计

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

入排标准

年龄范围
55 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • •55-79 yrs of age
  • Native English speaker
  • Having corrected vision sufficient to read 18pt font on a computer screen
  • Wearing binaural hearing aids that were fitted within the past 3 years that are the only hearing aids the subject has ever worn

排除标准

  • The hearing aids worn by the subject will be evaluated on the subject's ears and must be functioning as required for this study; otherwise, the subject will be excluded from participation until the hearing aids have been adjusted appropriately
  • asymmetrical hearing loss
  • presence of dementia, Parkinson's disease, or other neurological disorder

研究组 & 干预措施

Passive Control

No Intervention

Hearing aid alone

Training

Experimental

Auditory Training Program. Hearing aid plus auditory training

干预措施: Auditory training program (Behavioral)

Active control

Sham Comparator

Sham comparator: Active control. Hearing aid plus audio-book use

干预措施: Sham Comparator: Active Control (Behavioral)

结局指标

主要结局

Change in Connected Speech Test (CST) Score

时间窗: Baseline (prior to training) and 6-weeks later (after training)

The CST is an "objective" measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training.

次要结局

  • Change in Aided Profile of Hearing Aid Performance (PHAP) Score(Baseline (pre-training) and 6 weeks later (post training))

研究者

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

Larry Humes

Distinguished Professor

Indiana University

研究点 (2)

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