Evaluation of Auditory Mirror-therapy for Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Tinnitus Functional Index (TFI)
研究概览
简要总结
The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).
详细描述
The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.
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
- None
盲法说明
Concealment of treatment allocation is not possible
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Ages 18-80 years old
- •Chronic Tinnitus (> 3months)
排除标准
- •Use of hearing aids
- •No history of significant drug or alcohol use
- •No history of debilitating neurological or psychiatric illnesses
- •No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease
研究组 & 干预措施
Sham Headphone Device
Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector
干预措施: Auditory Mirror Therapy (Device)
Auditory Mirror Therapy Device
Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa.
干预措施: Auditory Mirror Therapy (Device)
结局指标
主要结局
Change in Tinnitus Functional Index (TFI)
时间窗: 3 weeks
The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity.
次要结局
- Change in Minimum Masking Level (MML) and Residual Inhibition (RI)(3 weeks)
- Change in Tinnitus Handicap Inventory (THI)(3 weeks)
- Change in Visual Analogue Scale (VAS)(3 weeks)
研究者
Nils Clas Linnman
Assistant Professor
Spaulding Rehabilitation Hospital