Eustachian Tube DysfunctionNCT02385175
The Accuracy of Tests of Eustachian Tube Function
An observational study of Eustachian Tube Dysfunction, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Different objective clinical tests of Eustachian tube function and Different patient-completed questionnaires relating to Eustachian tube dysfunction
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with Eustachian tube dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Different objective clinical tests of Eustachian tube function, Different patient-completed questionnaires relating to Eustachian tube dysfunction
- Keywords
- Eustachian tube, test accuracy, clinical test, questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different objective clinical tests of Eustachian tube functionOther
Different patient-completed questionnaires relating to Eustachian tube dysfunctionOther
| Study group | Role | What they receive |
|---|---|---|
| Adults with suspected Eustachian tube dysfunction | Age 18+ with possible Eustachian tube dysfunction on the basis of symptoms and examination findings. Receives: Other: Different objective clinical tests of Eustachian tube function; Other: Different patient-completed questionnaires relating to Eustachian tube dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Patients will undertake each assessment once in a single session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Tysome, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385175
- Sponsor's protocol ID
- 166405
- Status last verified
- Jun 2018
- First submitted
- 3 Mar 2015
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Tests of Eustachian Tube Function
- ClinicalTrials.gov ID
- NCT02385175
- Acronym / sponsor ID
- 166405
- Conditions
- Eustachian Tube Dysfunction
- Keywords
- Eustachian tube, test accuracy, clinical test, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with suspected Eustachian tube dysfunction | – | Other: Different objective clinical tests of Eustachian tube function, Other: Different patient-completed questionnaires relating to Eustachian tube dysfunctionAge 18+ with possible Eustachian tube dysfunction on the basis of symptoms and examination findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Eustachian tube dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Test sensitivity and specificity for assignment of patients to case or control groups
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eustachian Tube Dysfunction, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test sensitivity and specificity for assignment of patients to case or control groups (time frame: Patients will undertake each assessment once in a single session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.