Preliminary Clinical Trial of New Therapy for Patients with Severe Tinnitus

严重耳鸣患者新疗法的初步临床试验

• 批准号: 8325136
• 负责人: Debara L. Tucci
• 金额: $ 21.81万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8325136
• 关键词: Adherence; Adult; Alternative Therapies; Anxiety; Arousal; Audiology; Auditory; Auditory system; Autonomic nervous system; Award; Caring; Characteristics; Clinic; Clinical Trials; Country; Data; Devices; Disabled Persons; Disease; Enrollment; Equipment and supply inventories; Expectancy; Financial compensation; Functional disorder; Future; Goals; Hearing; Individual; Injury; Integrative Medicine; Intention; Investigation; Life; Limbic System; Loudness; Measures; Medical; Mental Depression; Otolaryngology; Outcome Measure; Patients; Peripheral; Pharmaceutical Preparations; Prevalence; Process; Protocols documentation; Quality of life; Reporting; Sampling; Secondary to; Sensory Process; Site; Solutions; Stress; Symptoms; Target Populations; Techniques; Testing; Therapeutic; Therapeutic Intervention; Tinnitus; United States Department of Veterans Affairs; Veterans; base; clinically significant; coping; coping mechanism; depressive symptoms; design; disability; economic impact; effective therapy; empowered; evidence base; experience; handicapping condition; holistic approach; improved; innovation; novel strategies; patient oriented; patient population; practice-based research network; primary outcome; programs; response; satisfaction; secondary outcome; sound; tinnitus retraining therapy; treatment effect; treatment strategy; trend; willingness

DESCRIPTION (provided by applicant): Tinnitus is a common problem for which there is no universally effective treatment. The best available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but only 20% of those who report tinnitus suffer from it and subsequently seek treatment. 1 Only formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over $345.5 million.2 Individuals with persistent severe tinnitus are unable to habituate to the tinnitus sound that most likely originates in the central auditory system (CAS) in response to peripheral injury. In a widely referenced study, it has been hypothesized that lack of habituation is secondary to abnormal processing of sensory information. Specifically, processing by the limbic system and autonomic nervous system is apparently abnormal in patients with increased levels of cortical arousal and inadequate coping mechanisms. 3,4 In otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment, additional treatment options are necessary particularly for those with significant non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who do not experience significant improvement with SBE. 5 Furthermore, commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year to become effective and may not be used in patients with hearing that is too poor to be modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment and the known percentage who do not respond to commonly used therapies,5 we estimate that 1.2 million individuals are not able to benefit at all from current, widely used treatment strategies. A new strategy to augment those currently used could empower patients to exert control over their tinnitus symptoms without the use of medications, expensive devices such as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be useful both for patients who are not candidates for SBE and for those who respond poorly. An Integrative Medicine approach provides a likely solution. To date, there has been no systematic study of the benefits of an Integrative Medicine approach for severe tinnitus, particulary for non-auditory aspects of tinnitus symptoms. The goal of the proposed study is to determine if an integrative medicine approach which targets treatment of the non- auditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms when added to current commonly applied SBE therapies, compared with SBE alone. If successful, this approach will be applied to a larger patient population in future studies to test the generalizability and the durability of the effect. Our eventual goal is to develop a streamlined approach that individualizes tinnitus treatment based on symptoms and patient characteristics, and that can be widely applied in general medical practice.

描述（由申请人提供）：耳鸣是一种常见问题，目前尚无普遍有效的治疗方法。现有的最佳估计表明，10 - 15% 的成年人报告有耳鸣症状，但只有 20% 报告有耳鸣的人患有耳鸣并随后寻求治疗。 1 仅由美国退伍军人事务部 (VA) 正式报告，耳鸣的经济影响被认为是巨大的。退伍军人管理局 2004 年报告称，289,159 名退伍军人因耳鸣获得了伤残奖，年度赔偿总额超过 3.455 亿美元。2 患有持续性严重耳鸣的个人无法习惯最有可能源自中枢听觉系统的耳鸣声音（CAS）响应外周损伤。在一项被广泛引用的研究中，人们假设缺乏习惯是感官信息处理异常的继发因素。具体来说，在皮质唤醒水平增加和应对机制不足的患者中，边缘系统和自主神经系统的处理明显异常。 3,4 在耳鼻喉科和听力学诊所中，“基于声音的教育疗法”(SBE) 是大多数当前疗法的重点，并利用增强的 CAS 声音输入。虽然 SBE 治疗很可能为耳鸣治疗提供一个起点，但额外的治疗选择是必要的，特别是对于那些患有严重耳鸣非听觉方面（例如焦虑、抑郁、干扰日常生活）以及那些没有经历过耳鸣的人SBE 显着改善。 5 此外，常用的 SBE 形式 [例如耳鸣再训练疗法 (TRT)] 可能需要一年多的时间才能生效，并且可能不适用于听力太差而无法通过声音输入改变的患者。根据寻求治疗的耳鸣患者的患病率数据以及对常用疗法没有反应的已知百分比5，我们估计有 120 万人根本无法从当前广泛使用的治疗策略中受益。一种增强目前使用的方法的新策略可以使患者能够控制耳鸣症状，而无需使用药物、昂贵的设备（例如 Neuromonics 设备）或扩展程序（例如 TRT）。另一种策略可能对不适合 SBE 的患者和反应不佳的患者都有用。综合医学方法提供了一个可能的解决方案。迄今为止，还没有系统研究中西医结合治疗方法对严重耳鸣的益处，特别是对耳鸣症状的非听觉方面的益处。拟议研究的目的是确定与单独使用 SBE 相比，将针对耳鸣非听觉方面的治疗的综合医学方法添加到当前常用的 SBE 疗法中是否能更有效地缓解耳鸣症状。如果成功，这种方法将在未来的研究中应用于更大的患者群体，以测试效果的普遍性和持久性。我们的最终目标是开发一种简化的方法，根据症状和患者特征进行个体化耳鸣治疗，并且可以广泛应用于一般医疗实践。

项目成果

Complementary Therapies for Significant Dysfunction from Tinnitus: Treatment Review and Potential for Integrative Medicine.

耳鸣严重功能障碍的补充疗法：治疗回顾和综合医学的潜力。

• 发表时间: 2015
• 作者: Wolever, Ruth Q;Price, Rebecca;Hazelton, A Garrett;Dmitrieva, Natalia O;Bechard, Elizabeth M;Shaffer, Janet K;Tucci, Debara L
• 通讯作者: Tucci, Debara L