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

机译:耳鸣研究协会支持的临床试验:经验教训,伊利诺伊州南部大学的经验

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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:耳鸣研究协会在南伊利诺伊大学医学院资助了三项临床试验,研究了慢性打扰性耳鸣的治疗方法。设计这些试验的目的是使用标准调查表测量主观耳鸣困扰的变化,并使用心理物理匹配程序测量耳鸣响度的客观变化。前两个试验的结果已经发布,并在此处汇总。第一次试验研究了加巴喷丁对患有和无声损伤史的慢性耳鸣患者的耳鸣响度和烦恼的影响。少数但大量的受试者报告耳鸣烦恼减少,这与在积极药物治疗期间耳鸣响度的客观测量值降低以及安慰剂治疗期间的冲洗效应相对应。第二项试验将耳鸣再训练疗法(TRT)对听力正常至接近正常的成年人和慢性困扰性耳鸣的治疗效果与未进行声波强化的一般咨询治疗进行了比较。在两个治疗组中,耳鸣的严重程度均得到了显着改善,但耳鸣响度的客观心理测量却没有改善,但是与对照组相比,在TRT组中观察到了更大的效果。第三项试验已接近尾声,并研究了耳聋成年患者慢性耳鸣的耳鸣再训练治疗的长期效果。从这三个试验中获得了有关进行耳鸣临床试验的重要经验教训。讨论了招募和留住研究参与者的挑战。更重要的是,提出了较长时间间隔内耳鸣残障清单(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。本文是名为的特刊的一部分。 (C)2015 Elsevier B.V.保留所有权利。

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