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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02385175
Other study ID # 166405
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date June 2017

Study information

Verified date June 2018
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Different objective clinical tests of Eustachian tube function

Different patient-completed questionnaires relating to Eustachian tube dysfunction


Locations

Country Name City State
United Kingdom Addenbrooke's Hospital Cambridge

Sponsors (1)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test sensitivity and specificity for assignment of patients to case or control groups Each test will be interpreted as per standard practice, using a validated method where available Patients will undertake each assessment once in a single session
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