Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial

抑制耳鸣的缺口噪声疗法：一​​项随机对照试验

• 批准号: 10543404
• 负责人: Candice Manning Quinn
• 金额: --
• 依托单位: DURHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10543404
• 关键词: Acoustics; Adopted; Aftercare; Area; Attention; Auditory; Auditory Evoked Potentials; Behavioral; Caring; Chronic; Clinical; Clinical Research; Development; Devices; Ear; Electroencephalography; Electrophysiology (science); Enrollment; Evaluation; Evidence based treatment; Exhibits; Foundations; Frequencies; Goals; Health; Hearing Aids; Hour; Immersion; Individual; Intervention; Lateral; Loudness; Loudness Perception; Maintenance; Measures; Methods; Military Personnel; Neuraxis; Noise; Outcome; Outcome Assessment; Outcome Measure; Participant; Patient Self-Report; Patients; Perception; Physiological; Post-Traumatic Stress Disorders; Process; Protocols documentation; Psychoacoustics; Randomized; Randomized Controlled Trials; Reaction; Research; Research Support; Research Training; Services; Severities; Shapes; Sleep disturbances; Solid; Stimulus; Therapeutic Intervention; Tinnitus; Training; Training Programs; Traumatic Brain Injury; Veterans; Work; base; career; catalyst; disability; efficacy evaluation; emotional distress; evidence base; experience; habituation; hearing impairment; help-seeking behavior; indexing; insight; instrument; military veteran; neurophysiology; notch protein; patient oriented; programs; relating to nervous system; sensory gating; sound; therapy development; tool; treatment center; treatment duration; trial comparing

Tinnitus is the most prevalent service-connected disability for Veterans. Many Veterans are offered sound- based (acoustic) therapy for tinnitus that is intended to alter the tinnitus perception and/or reactions to tinnitus in a clinically beneficial way. Various methods of acoustic therapy are in use and companies are promoting different products. It remains unknown; however, how certain acoustic parameters may be more effective than others. Recent research has shown the benefit of one such acoustic therapy, Notched Noise Therapy, that presents wideband sound with the tinnitus frequency region notched out, theorized to distribute lateral inhibition into the notched frequency region to suppress neural activity believed to cause the tinnitus percept. Previous studies have typically involved brief daily exposures, which are not as likely to remodel neural processes underlying tinnitus as is continuous “immersion” in background sound, which is adopted here. The proposed study will conduct a randomized controlled trial to evaluate the efficacy of notched noise therapy (NNT). The long-term goal of our research program is to develop an accessible, evidence-based treatment that reduces tinnitus loudness and to be able to assess that treatment through a validated method of behavioral and physiological clinical tools. The overall objective for this CDA-2 research plan, which is the next step toward attainment of our long-term goal, is to systematically evaluate the utility of functional, psychoacoustic, and electrophysiologic measures to reveal the overall whole-health impact in Veterans with chronic tinnitus. The trial will enroll 108 participants, who will be randomized to one of three acoustic therapy methods: amplification + notched noise, amplification + noise without notch, and amplification-only. The three groups will be asked to wear ear-level devices (combination instruments that provide both amplification and 1-10 kHz shapeable noise) as much as possible during waking hours. All participants will undergo acoustic therapy for 8 weeks and will complete outcome measures (i.e., Tinnitus Functional Index, Psychoacoustic loudness and pitch matches, AEP, and EEG measures) at baseline and at 4 and 8 weeks. They will repeat outcome assessment at 12 weeks to evaluate for maintenance of any effects while not receiving acoustic therapy for 4 weeks. (Participants requiring hearing aids for hearing loss will continue to use their aids during the 4-week no- treatment period). We hypothesize that NNT suppresses tinnitus perception by distributing lateral inhibition into the notched frequency region and will therefore, reduce the perception of tinnitus loudness. At the completion of this CDA-2 program, the expected outcomes include a NNT as a therapy for tinnitus and the contributions that it may have on tinnitus perception as well as a solid training foundation for a successful VA research career. These results are expected to have an important positive impact because they will not only provide insight into the true reactionary and perceptual benefit of an intervention, but a treatment evaluation protocol will be determined, ultimately providing a foundation for the development of evidence-based acoustic therapies to treat tinnitus, a critical component and goal of Veteran tinnitus care.

耳鸣是退伍军人中最常见的与服务有关的残疾。许多退伍军人提供健全的- 耳鸣的基础（声学）治疗，旨在改变耳鸣的感觉和/或反应耳鸣 在临床上是有益的。各种方法的声学治疗正在使用和公司正在推广 不同的产品。它仍然是未知的;然而，某些声学参数如何可能比 他人最近的研究表明，一个这样的声音治疗，陷波噪声治疗的好处， 呈现宽带声音，耳鸣频率区域被切出，理论上分布在横向 抑制进入陷波频率区域以抑制被认为引起耳鸣的神经活动。 以前的研究通常涉及短暂的日常暴露，这不太可能重塑神经系统。 处理潜在的耳鸣，因为它是连续的“沉浸”在背景声音中，这是这里采用的。的 拟议的研究将进行一项随机对照试验，以评估缺口噪音治疗的疗效 （NNT）。我们研究计划的长期目标是开发一种可获得的，基于证据的治疗方法， 降低耳鸣响度，并能够通过有效的行为方法评估治疗 和生理临床工具。CDA-2研究计划的总体目标是， 为了实现我们的长期目标，是系统地评估功能，心理声学， 和电生理措施，以揭示整体整体健康的影响，退伍军人与慢性耳鸣。 该试验将招募108名参与者，他们将被随机分配到三种声学治疗方法之一： 放大+陷波噪声、放大+无陷波噪声和仅放大。三个小组将 要求佩戴耳位设备（提供放大和1-10 kHz的组合仪器） 在清醒的时候尽可能多地发出噪音。所有参与者将接受8个月的声学治疗， 周，并将完成结果测量（即，听觉功能指数、心理声学响度和 音高匹配、AEP和EEG测量）。他们会重复结果 在12周时进行评估，以评价在4周内未接受声学治疗时维持任何效果 周（需要助听器治疗听力损失的参与者将在为期4周的不使用助听器期间继续使用助听器。 治疗期）。我们假设NNT通过将侧抑制分布到 陷波频率区域，因此将降低耳鸣响度的感觉。完成时 的CDA-2计划，预期的结果包括NNT作为耳鸣的治疗和贡献 它可能对耳鸣的感知以及一个成功的VA研究坚实的训练基础 事业这些成果预计将产生重要的积极影响，因为它们不仅将提供 深入了解干预的真正反应和感知益处，但治疗评估方案 将被确定，最终为基于证据的声学治疗的发展提供基础 耳鸣的治疗方法有哪些？耳鸣的治疗方法有哪些