背景:梅尼埃病是一种特发性疾病,其特征是反复发作的眩晕持续时间超过20分钟,单侧感觉神经性听力损失,还有耳鸣.如果眩晕发作频繁,患者通常严重丧失工作能力。目前,关于梅尼埃病的治疗尚无共识。由于缺乏随机试验以及随着时间的推移经常自发缓解和相当大的安慰剂效应,有关大多数治疗选择的证据很少。插入肌动膜管是一种简单且相对安全的方法,微创手术和以前的开放标签试验显示了有希望的结果.
方法:这是一个前瞻性的,假控制,双盲,随机化,临床试验。
目的:本试验旨在评估在鼓膜中插入通气管与假治疗对明确或可能的单侧梅尼埃病的影响。
结果:主要结果是持续超过20分钟的自发性眩晕发作次数和治疗失败的时间。除了主要结果,我们将评估与听力相关的各种次要结果,耳朵丰满,头晕,和严重不良事件。
方法:估计总共104名参与者或每组52名参与者将是必要的。主要分析将根据意向治疗原则进行。该试验将于2021年开始,预计将于2025年结束。
方法:ClinicalTrials.gov:NCT04835688。2021年4月8日注册。
方法:1.8,26-09-2022。首次报名日期:10月1日,2021年。研究结束:预计2025年1月。
BACKGROUND: Menière\'s disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, the patient is usually severely incapacitated. Currently, there is no consensus on the treatment of Menière\'s disease. The evidence regarding most treatment options is sparse due to a lack of randomized trials together with an often-spontaneous relief over time and a considerable placebo effect. Insertion of a transmyringeal tube is a simple and relatively safe, minimally invasive procedure and previous open-label trials have shown promising results.
METHODS: This is a prospective, sham-controlled, double-blinded, randomized, clinical trial.
OBJECTIVE: This trial aims to assess the effects of inserting a ventilation tube into the tympanic membrane compared with sham treatment for definite or probable unilateral Menière\'s disease according to the criteria formulated by the Classification Committee of the Bàràny Society.
RESULTS: The primary outcome will be the number of spontaneous vertigo attacks lasting more than 20 min and time to treatment failure. In addition to the primary outcome, we will assess various secondary outcomes related to hearing, ear fullness, dizziness, and serious adverse events.
METHODS: An estimated 104 participants in total or 52 participants in each group will be necessary. The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025.
METHODS: ClinicalTrials.gov : NCT04835688 . Registered on April 8, 2021.
METHODS: 1.8, 26-09-2022. Date of first enrollment: October 1st, 2021. End of study: anticipated January 2025.