OCT Imaging and Vibrometry in Patients With Hearing Loss: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Vibrometry (Ossicular mobility in mm/s/Pa)
研究概览
简要总结
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
详细描述
This study is an exploratory clinical investigation to obtain pilot imaging and vibrometry data in patients with various hearing loss aetiologies and to identify qualitative and quantitative features associated with specific pathologies. The data collected in this study is intended to support future investigations into the accuracy of the system in diagnosing specific middle ear disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 ages 18+ Conductive or sensorineural hearing loss -
排除标准
- •Adults with normal hearing Children Subjects unable to understand Informed consent
结局指标
主要结局
Vibrometry (Ossicular mobility in mm/s/Pa)
时间窗: 2 years
Optical Coherenece Tomography vibrometry measures of ossicular mobility for the umbo and incus in mm/s/Pa for 6 frequencies of 500, 750, 1000, 1500, 2000 and 3000 Hz
Standard audiometry--threshold measurement in dBHL
时间窗: 2 years
Standard pure tone and bone conduction audiometry--measurement of acoustic thresholds for air and bone conductive stimuli at 250, 500, 1000, 2000, 3000 , 4000, 6000 and 8000 Hz
Standard tympanometry--measurement of acoustic immittance in daPa
时间窗: 2 years
Standard tympanometric testing of ear canal volume and middle ear immittance
次要结局
未报告次要终点