The Accuracy of Tests of Eustachian Tube Function

NHS Foundation Trust

Status: Completed

Conditions: Eustachian Tube Dysfunction

Treatments: Other: Different patient-completed questionnaires relating to Eustachian tube dysfunction; Other: Different objective clinical tests of Eustachian tube function

Study type: Observational

Funder types: Other

Identifiers

NCT02385175

166405

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Trial design

116 participants in 1 patient group

Adults with suspected Eustachian tube dysfunction

Description:

Age 18+ with possible Eustachian tube dysfunction on the basis of symptoms and examination findings.

Treatment:

Other: Different patient-completed questionnaires relating to Eustachian tube dysfunction

Other: Different objective clinical tests of Eustachian tube function