The Accuracy of Tests of Eustachian Tube Function

NCT02385175 | Completed

• 1 other identifier: 166405
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Dysfunction

Keywords

Eustachian tube; test accuracy; clinical test; questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adults with suspected Eustachian tube dysfunction

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

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

Interventions

Different objective clinical tests of Eustachian tube function OTHER

Adults with suspected Eustachian tube dysfunction

Different patient-completed questionnaires relating to Eustachian tube dysfunction OTHER

Adults with suspected Eustachian tube dysfunction

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 11, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

GB (1)