Assessing the Sensitivity and Specificity of Sonotubometry to Measure the Eustachian Tube Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer
研究概览
简要总结
The Eustachian tube (ET) connects the middle ear with the throat and is important for maintaining a healthy middle ear. Sonotubometry is a new method to measure how well the ET works by using sound. A speaker is placed at the nostril and a microphone records sound in the external ear canal. The ET is closed at rest and opens with swallowing. This is measured as an increase in sound measured in the external ear by sonotubometry.
Previous research has not proven that sonotubometry is reliable enough to be used in clinics to assess ET dysfunction (a disease where the ET does not open properly). In a recent study with healthy volunteers, it was possible to identify many of the existing issues of sonotubometry and improve the reliability of this method. This was primarily achieved by testing different sound types and sound volumes. This study aims to assess the reliability and usability of the new testing protocol in study participants with ET dysfunction. The results of this study will then be compared with the results from the previous study with healthy volunteers to work out how well sonotubometry works. Ultimately, this research aims to improve the ability to diagnose ET dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The order of the assessment measurements is batch-wise randomised but there is no masking. Both the participant and investigator know what sort of measurements is being performed.
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is capable of giving informed consent (in the English language)
- •Participant has a current diagnosis of obstructive Eustachian tube dysfunction in the ear clinic at Addenbrooke's Hospital
- •Age 16 and over
排除标准
- •Cardiac pacemaker (incompatible with the large sonotubometry speaker magnet)
- •Discharging or infected ear (for infection control reasons)
- •Otitis Media with effusion (complicates test interpretation)
- •Cleft palate or Craniofacial abnormalities (complicates test interpretation)
- •Cholesteatoma (complicates test interpretation)
- •Nasopharyngeal mass (complicates test interpretation)
- •History of radiotherapy to the head and neck (can affect surrounding tissue structure)
结局指标
主要结局
Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer
时间窗: 40-50 minutes
The main objective of the trial is to measure the specificity and sensitivity of an assessment method of the Eustachian tube called sonotubometry. To do this, eight sonotubometry measurements will be performed on each patient using the custom built Sonotubometry device. In total a maximum of 28 patients will be measured. This data will be compared to measurements from volunteers (data collected through a different study) to measure the sensitivity and specificity in percentage.
次要结局
- Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude(40-50 minutes)
研究者
James Tysome
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust