NCT05582148Unknown不适用
Meniere Disease and Hearing Aids
University Hospital, Grenoble0 个研究点目标入组 10 人开始时间: 2022年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Evaluation of the comprehension in noise
研究概览
简要总结
Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis.
Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients.
Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age over 18 y.o
- •Meniere disease as define by the Barany Society
- •Unilateral deafness with a threshold over 50dB
- •Normal ear with a threshold above 30dB
- •Interaural threshold difference of at least 30dB
- •Patient who has already an hearing aids and satisfied with it
排除标准
- •Absence of consent of the patient or not able to give it
- •Patient with hearing aids well fitted
结局指标
主要结局
Evaluation of the comprehension in noise
时间窗: 6 months
Evaluation with the FrMatrix test of the noise comprehension at 6 months
次要结局
- Correlation between the ear recruitment and the settings of the hearing aids(6 months)
研究者
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