NCT00124800已完成1 期
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
Tinnitus Research Consortium2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in objective measure of tinnitus loudness using psychoacoustic matching task
研究概览
简要总结
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.
详细描述
The specific aims of the study are to:
- Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
- Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
- Determine the therapeutic time course of improvement in tinnitus.
- Determine the long-term improvement in tinnitus derived from TRT.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic non-pulsatile tinnitus
排除标准
- •Hyperacusis
- •Subjective hearing loss
- •Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
- •Evidence of significant depression or suicidal ideation
结局指标
主要结局
Change in objective measure of tinnitus loudness using psychoacoustic matching task
时间窗: 18 months
Change in subjective handicap rating of tinnitus using a standardized questionnaire
时间窗: 18 months
次要结局
- Change in subjective ratings of tinnitus loudness, annoyance and awareness(18 months)
研究者
研究点 (2)
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