Sudden Hearing Loss Multicenter Treatment Trial

突发性听力损失多中心治疗试验

• 批准号: 6908182
• 负责人: Steven D. Rauch
• 金额: $ 124.53万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-17 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6908182
• 关键词: adult human (21+); audiometry; clinical research; clinical trials; cooperative study; corticosteroid analog; drug adverse effect; ear disorder chemotherapy; hearing; human subject; human therapy evaluation; injection /infusion; methylprednisolone; nervous system disorder chemotherapy; oral administration; patient oriented research; prednisone; sensorineural hearing loss; therapy adverse effect; tympanum

DESCRIPTION (provided by applicant): The overall objective of this project is to compare the efficacy of two different treatments for idiopathic sudden sensorineural hearing loss (SSNHL). SSNHL is an otologic emergency causing unilateral deafness of variable severity. If treated promptly with a short course of oral corticosteroids, approximately 60% of patients regain some hearing. However, in patients with severe-to-profound SSNHL it is rare to fully recover hearing. Increasing duration of oral steroid therapy beyond three to four weeks has never been shown to improve hearing outcome, and the risk of steroid side effects rises with greater duration of treatment. Recent animal studies of corticosteroid penetrance into the inner ear and reports of treatment outcome in several small uncontrolled series of SSNHL patients suggest that local administration of corticosteroids by intratympanic (IT) injection may achieve equivalent or better hearing recovery while lowering the potential risk of systemic side effects. In this project we propose a multicenter prospective randomized clinical trial to compare the efficacy of oral prednisone vs. IT methylprednisolone for primary treatment of SSNHL. All qualified subjects will be randomized to receive either two weeks or oral prednisone or two weeks of IT methylprednisolone injections. The two Specific Aims of the study are to: (1) test the primary hypothesis that IT corticosteroids are as effective as oral prednisone for primary SSNHL treatment; and (2) compare the side-effects and adverse events in subjects treated with oral or IT steroids. The project is designed as an equivalency study. If the primary hypothesis of equivalency is supported, results of the second Specific Aim, comparison of side-effects, will guide clinical practice. If the two treatments are not equivalent, the study design enables us to detect which is better and by how much. Thus the results of this study will have significant impact on evidence-based clinical practice guidelines for management of SSNHL. This application is for the collaborating Clinical Coordinating Center (CCC).

描述（由申请人提供）： 本项目的总体目标是比较两种不同治疗方法对特发性突发性感音神经性听力损失（SSNHL）的疗效。SSNHL是一种耳科急症，可引起不同严重程度的单侧耳聋。如果及时给予短期口服皮质类固醇治疗，大约60%的患者可以恢复一些听力。然而，在严重到极深的SSNHL患者中，听力完全恢复是罕见的。增加口服类固醇治疗的持续时间超过三到四周从未被证明可以改善听力结果，并且类固醇副作用的风险随着治疗时间的增加而增加。最近的动物研究表明，皮质类固醇激素进入内耳，并在几个小的非对照系列的SSNHL患者的治疗结果的报告表明，局部给药的皮质类固醇鼓室内（IT）注射可以实现等效或更好的听力恢复，同时降低全身副作用的潜在风险。在这个项目中，我们提出了一个多中心的前瞻性随机临床试验，比较口服强的松与IT甲基强的松龙的疗效原发性治疗SSNHL。所有合格的受试者将随机接受2周或口服泼尼松或2周IT甲泼尼龙注射。本研究的两个具体目的是：（1）检验IT皮质类固醇与口服泼尼松一样有效治疗原发性SSNHL的主要假设;（2）比较口服或IT类固醇治疗受试者的副作用和不良事件。该项目是作为一项等效性研究设计的。如果等同性的主要假设得到支持，则第二个特定目的（副作用比较）的结果将指导临床实践。如果两种治疗方法不等同，研究设计使我们能够检测哪种方法更好以及更好的程度。因此，这项研究的结果将有显着的影响，以证据为基础的临床实践指南的管理SSNHL。此应用程序是为合作的临床协调中心（CCC）。