Clinical Trials Directory

Trials / Completed

CompletedNCT02385175

The Accuracy of Tests of Eustachian Tube Function

Status
Completed
Phase
Study type
Observational
Enrollment
116 (actual)
Sponsor
Cambridge University Hospitals NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERDifferent objective clinical tests of Eustachian tube function
OTHERDifferent patient-completed questionnaires relating to Eustachian tube dysfunction

Timeline

Start date
2016-02-01
Primary completion
2017-05-01
Completion
2017-06-01
First posted
2015-03-11
Last updated
2018-06-27

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02385175. Inclusion in this directory is not an endorsement.