Sudden Hearing Loss Multicenter Treatment Trial

突发性听力损失多中心治疗试验

• 批准号: 7246458
• 负责人: Steven D. Rauch
• 金额: $ 118.46万
• 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/7246458
• 关键词: Academy; Adrenal Cortex Hormones; Adverse effects; Adverse event; American; Animals; Anticoagulants; Antiviral Agents; Autoimmune Process; Blood Vessels; Breathing; Carbogen; Caring; Case Series; Clinical; Clinical Practice Guideline; Consensus; Drug Delivery Systems; Drug Kinetics; Educational process of instructing; Emergency Situation; English Language; Etiology; Evidence based treatment; Failure; Frequencies; Gentamicins; Head and Neck Surgery; Hearing; Inflammation; Injection of therapeutic agent; Ischemia; Labyrinth; Localized; Membrane; Meniere' s Disease; Methods; Methylprednisolone; Oral; Oral Administration; Otolaryngology; Outcome; Pain; Patients; Penetrance; Perforation; Pharmaceutical Preparations; Prednisone; Publications; Qualifying; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Reporting; Research Design; Risk; Rupture; Sensorineural Hearing Loss; Series; Severities; Speech Audiometry; Steroid therapy; Steroids; Sudden Hearing Loss; Techniques; Testing; Treatment Efficacy; Treatment outcome; Tympanic membrane; Unilateral Hearing Loss; United States; Viral; Week; base; cohort; design; hearing impairment; improved; interest; prospective; success; treatment duration; treatment trial

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）： 该项目的总体目标是比较两种不同治疗方法对特发性突发感音神经性听力损失（SSNHL）的疗效。 SSNHL 是一种耳科急症，可导致不同严重程度的单侧耳聋。如果及时接受短期口服皮质类固醇治疗，大约 60% 的患者会恢复部分听力。然而，重度至极重度 SSNHL 患者的听力很少能完全恢复。增加口服类固醇治疗的持续时间超过三到四个星期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持续时间的延长而增加。最近对皮质类固醇渗透到内耳的动物研究以及几个小规模不受控制的 SSNHL 患者的治疗结果报告表明，通过鼓室内 (IT) 注射局部给予皮质类固醇可以实现同等或更好的听力恢复，同时降低全身副作用的潜在风险。在该项目中，我们提出了一项多中心前瞻性随机临床试验，以比较口服泼尼松与 IT 甲基泼尼松龙对 SSNHL 初级治疗的疗效。所有合格受试者将随机接受两周口服泼尼松或两周 IT 甲泼尼龙注射。该研究的两个具体目标是：(1) 检验 IT 皮质类固醇对于主要 SSNHL 治疗与口服泼尼松一样有效的主要假设； (2) 比较口服类固醇或 IT 类固醇治疗受试者的副作用和不良事件。该项目被设计为等效研究。如果等效性的主要假设得到支持，第二个具体目标（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效，研究设计使我们能够检测哪种方法更好以及效果好多少。因此，这项研究的结果将对 SSNHL 管理的循证临床实践指南产生重大影响。此申请适用于合作临床协调中心 (CCC)。