At-home Auditory Training Clinical Trial
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
- 否
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
Hearing aid alone
Training
Auditory Training Program. Hearing aid plus auditory training
干预措施: Auditory training program (Behavioral)
Active control
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
Larry Humes
Distinguished Professor
Indiana University
