The Accuracy of Tests of Eustachian Tube Function

Eustachian Tube Dysfunction Clinical Trial

Official title:

The Accuracy of Tests of Eustachian Tube Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385175
• Other study ID #: 166405
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction

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