A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in the Number of Monthly Vertigo Episodes
研究概览
简要总结
The purpose of this study is to investigate the efficacy of a mastoid treatment device in patients with active Ménière's disease that is not controlled by traditional medical management
详细描述
This is a single center, randomized, placebo-controlled trial of mastoid oscillation for treatment of Ménière's disease. Eligible subjects will be randomized using a 1:1 allocation to either mastoid oscillation or placebo (oscillator device that provides the same sound but no vibration of the mastoid) received for 30 minutes at four weekly study visits, with efficacy determination via change in frequency and severity of Ménière's symptoms following the final study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and older
- •Clinical diagnosis of Ménière's disease, with classical symptoms:
- •i. Episodic spinning vertigo ii. Fluctuating unilateral low frequency sensorineural hearing loss iii. Tinnitus iv. Aural fullness c. Failure of traditional medical management of Ménière's disease symptoms d. English language skills sufficient to provide informed consent to the study
排除标准
- •Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
- •Bilateral Ménière's disease
结局指标
主要结局
Change in the Number of Monthly Vertigo Episodes
时间窗: Baseline to 90 days
A patient reported measure of the number of vertigo episodes they have experienced in the past month.
次要结局
- Change in Average Pure Tone Threshold(Baseline to 90 days)
- Change in Percentage of Words Recognized(Baseline to 90 days)
- Change in Meniere's Functional Level(Baseline to 90 days)