The Accuracy of Tests of Eustachian Tube Function

Completed

• Conditions: Eustachian Tube Dysfunction
• Interventions: Other: Different objective clinical tests of Eustachian tube function; Other: Different patient-completed questionnaires relating to Eustachian tube dysfunction

• Registration Number: NCT02385175
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2016-02
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with suspected Eustachian tube dysfunction	Different objective clinical tests of Eustachian tube function	Age 18+ with possible Eustachian tube dysfunction on the basis of symptoms and examination findings.
Adults with suspected Eustachian tube dysfunction	Different patient-completed questionnaires relating to Eustachian tube dysfunction	Age 18+ with possible Eustachian tube dysfunction on the basis of symptoms and examination findings.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom