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Clinical trials supported by the Tinnitus Research Consortium: Lessons learned, the Southern Illinois University experience

机译:Tinnitus研究财团支持的临床试验:学习经验教训,南伊利诺伊州南部大学经验

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The Tinnitus Research Consortium funded three clinical trials investigating treatments for chronic bothersome tinnitus at Southern Illinois University School of Medicine. The trials were designed to measure the subjective changes in tinnitus distress using standardized questionnaires and objective changes in tinnitus loudness using psychophysical matching procedures. The results of the first two trials have been published and are summarized here. The first trial investigated the effect of gabapentin on the loudness and annoyance of tinnitus in adults with chronic bothersome tinnitus with and without a history of acoustic trauma. A small but significant number of subjects reported decreased tinnitus annoyance that corresponded with a decrease in objective measures of tinnitus loudness during active drug treatment with a washout effect during placebo treatment. The second trial compared the effect of tinnitus retraining therapy (TRT) on adults with normal to near-normal hearing and chronic bothersome tinnitus to treatment with general counseling without acoustic enrichment. Significant improvements in tinnitus severity, but not in objective psychometric measures of tinnitus loudness, occurred in both treatment groups, however a greater effect was observed in the TRT group compared with the control group. The third trial is nearing completion and investigates the long-term results of tinnitus retraining therapy on chronic bothersome tinnitus in adults with hearing loss. Significant lessons and observations on conducting tinnitus clinical trials were learned from these three trials. The challenges of recruiting and retaining study participants is discussed. More importantly, the reliability and stability of the Tinnitus Handicap Inventory (THI) over long intervals is presented. The implications of this variability for the design and interpretation of future tinnitus studies is discussed. This article is part of a Special Issue entitled . (C) 2015 Elsevier B.V. All rights reserved.
机译:Tinnitus Research Consortium资助了三项临床试验,调查伊利诺伊大学医学院南部的慢性伯爵耳鸣治疗治疗。试验旨在使用标准化问卷测量耳鸣窘迫的主观变化,并使用心理物理匹配程序使用耳鸣响度的客观变化。前两项试验的结果已发表,总结了。第一次试验研究了加巴彭本汀对患有慢性伯内尼耳鸣的耳鸣令人嘈杂的效果,患有声学创伤的历史。少量但大量的受试者报告耳鸣烦恼,这与在安慰剂治疗期间的受活力药物治疗期间耳鸣响度的客观措施降低。第二次试验比较了耳鸣再培养治疗(TRT)对近常正常听力和慢性伯爵耳鸣的效果,在没有声学富集的一般咨询治疗。两种治疗组发生耳鸣严重程度的显着改善,但不是客观心理测量曲目的耳鸣响应的措施,然而与对照组比较在TRT组中观察到更大的效果。第三次试验正在接近完成,并调查耳鸣再培训治疗的长期结果与听力损失的成年人慢性白斑耳鸣。从这三项试验中吸取了关于进行耳鸣临床试验的重要教训和观察。讨论了招聘和保留研究参与者的挑战。更重要的是,介绍了耳鸣障碍库存(Thi)的可靠性和稳定性。讨论了这种可变性对未来耳鸣研究的设计和解释的影响。本文是题为的特殊问题的一部分。 (c)2015 Elsevier B.v.保留所有权利。

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