The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tinnitus Functional Index
研究概览
简要总结
This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).
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
- Double (Participant, Outcomes Assessor)
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
- •Daily bothersome tinnitus for at least 3 months (TFI>15)
- •Normal hearing (25 dB HL from 125 Hz to 8 kHz)
- •Inexperienced hearing aid user
排除标准
- •Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
- •Objective or pulsatile tinnitus
- •Hearing thresholds >25 dB from 125 Hz to 8 kHz
研究组 & 干预措施
Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz)
Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated
干预措施: Hearing Aid with NR_4 (Device)
Placebo Comparator: no amplification
Device: hearing aids with no amplification. No noise cancelling activated
干预措施: Hearing Aid with NR_4 (Device)
结局指标
主要结局
Tinnitus Functional Index
时间窗: 3 weeks
Questionnaire assessing tinnitus related distress, consisting on 25 questions that can be answered with likert scale from 0 to 10 where 10 is the most extreme negative value
次要结局
- Tinnitus loudness(3 weeks)
- Tinnitus spectrum(3 weeks)
- Visual Analog Scale - annoyance(3 weeks)
- Visual Analog Scale - loudness(3 weeks)
研究者
Mie Joergensen
Postdoc
Technical University of Denmark