The Accuracy of Tests of Eustachian Tube Function

NCT ID: NCT02385175

Last Updated: 2018-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Eustachian Tube Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with suspected Eustachian tube dysfunction

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

Different objective clinical tests of Eustachian tube function

Intervention Type OTHER

Different patient-completed questionnaires relating to Eustachian tube dysfunction

Intervention Type OTHER

Interventions

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Different objective clinical tests of Eustachian tube function

Intervention Type OTHER

Different patient-completed questionnaires relating to Eustachian tube dysfunction

Intervention Type OTHER

Eligibility Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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James Tysome

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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166405

Identifier Type: -

Identifier Source: org_study_id

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