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临床试验/NCT02385175
NCT02385175已完成不适用

The Accuracy of Tests of Eustachian Tube Function

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1
主要终点
Test sensitivity and specificity for assignment of patients to case or control groups

研究概览

简要总结

The Eustachian tube links the middle ear to the back of the nose and is designed to open to allow the pressure in the air-filled middle ear to be equal to external (atmospheric) pressure. In some people this system fails to work properly leading to abnormal pressure in the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'. An affected person may feel pressure, pain or other symptoms in their ear, and their hearing can be temporarily or permanently reduced.

This study is designed to find out which of a number of simple tests is best at detecting if the Eustachian tube is performing normally. Both patient-completed questionnaires and clinical tests using specialist machines will be compared as a way of diagnosing Eustachian tube dysfunction.

A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a similar group of people that are already known to have Eustachian tube dysfunction, will both take six different tests and complete four different questionnaires. The differences in the results between the group with ETD and the healthy group will be compared. The results for each test or questionnaire will be compared to see which is best at telling the healthy and Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube dysfunction. The investigators will also look to see if a combination of one or more of the tests or questionnaires is best at diagnosing the disease.

The results of this study hope to provide a test or combination of tests that can be used on a daily basis by ENT doctors. The assessment technique would also be helpful in researching and comparing new treatments for ETD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Test sensitivity and specificity for assignment of patients to case or control groups

时间窗: Patients will undertake each assessment once in a single session

Each test will be interpreted as per standard practice, using a validated method where available

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Tysome

Principle Investigator

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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