Hearing Aid Benefit in Adults With Self-Reported Hearing Difficulty Yet Normal Pure-Tone Audiograms (Duke sIRB)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Revised Hearing Handicap Inventory (RHHI)
研究概览
简要总结
The purpose of this study is to determine if hearing aid use helps adults with "normal" hearing on clinical hearing tests (i.e., pure-tone audiogram), but who report hearing trouble in everyday life. Another purpose is to understand what factors and hearing aid features provide the most help for these people.
详细描述
Participants will be randomly assigned to a hearing aid group and asked to wear a pair of hearing aids with a certain setting for 4 weeks, take a 4-week break, then wear hearing aids with a different setting for 4 weeks. Participants will complete several hearing-related assessments before and after each trial of hearing aids and share their experiences with each hearing aid setting. This study includes four research visits at a research laboratory at Duke University or The Ohio State University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults (≥18 years) presenting with "normal hearing" (pure-tone thresholds ≤25 dB HL from 250-4000 Hz) but hearing trouble (≥20 points on RHHI questionnaire)
- •Are willing to try amplification (i.e., hearing aids) for the first time
- •Can Read/write in American English
- •Have access to email, internet, and phone
排除标准
- •Participants with self-reported otologic history (e.g., ear surgery, ototoxic medications, middle-ear dysfunction, holes in ear drums)
- •Have moderate to severe traumatic brain injury
- •Have bothersome tinnitus as their primary complaint
- •Have a health condition that would interfere with study participation (e.g., dementia/cognitive disorder, blindness)
- •Prior hearing aid use
研究组 & 干预措施
Open-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with open domes, which have holes or vents that let natural sound and air pass into the ear canal.
干预措施: Signal-to-Noise Ratio Enhancement (SNR+) (Other)
Open-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with open domes, which have holes or vents that let natural sound and air pass into the ear canal.
干预措施: Signal-to-Noise Ratio Neutral (SNR-) (Other)
Closed-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.
干预措施: Signal-to-Noise Ratio Enhancement (SNR+) (Other)
Closed-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.
干预措施: Signal-to-Noise Ratio Neutral (SNR-) (Other)
结局指标
主要结局
Revised Hearing Handicap Inventory (RHHI)
时间窗: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
18-item questionnaire that assesses self-perceived hearing difficulty associated with social and emotional situations and is considered a hearing-related quality of life measure. Higher scores indicate MORE hearing difficulty. Administered unaided and aided. Scores range from 0 - 72.
次要结局
- Abbreviated Profile of Hearing Aid Benefit (APHAB)(Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2))
- Words in Noise (WIN) Test(Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2))