Eustachian Tube Dysfunction Clinical Trial
Official title:
Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults With Clinically Diagnosed Chronic Otitis Media With Effusion and/or Eustachian Tube Dysfunction
Verified date | November 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This research study measures how well the Eustachian tube works and looks directly at the
anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted
into their eardrums because they have been diagnosed as having either "otitis media" or
"poor Eustachian tube function". The Eustachian tube is a biologic tube that connects the
back of the nose to the middle ear (the airspace located behind your eardrum). That tube is
usually closed, but can be opened by swallowing and other activities. Periodic openings of
the Eustachian tube allow air to flow between the nose and middle ear which keeps the
pressure of gas in the middle ear at the same level as that of the atmosphere, a condition
required for good hearing. In children and adults, middle-ear diseases such as otitis media
with effusion (the buildup of fluid within the middle ear) and a form of temporary hearing
loss (conductive hearing loss) occur if the Eustachian tube does not open, does not open
frequently enough or is always open (called a patulous Eustachian tube). A diagnosis of
these different conditions can be made using standard, clinical tests of Eustachian tube
function and the Eustachian tube can be visualized where it enters the back of the nose
using a specialized telescope called an endoscope. Some scientific reports suggest that the
cause of poor Eustachian tube function in an individual can be determined by studying the
anatomy of the Eustachian tube at the back of the nose and the movements of the Eustachian
tube in that area during swallowing, talking and other activities using an endoscope.
In this study, the investigators plan to explore the relationship between the results of the
standard Eustachian tube function tests and those for the anatomy and function of the
Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian
tube function. Also, there are a number other disease conditions (examples: nasal allergy,
acid reflux disease) that are related to poor Eustachian tube function and it is possible
that these conditions and their effect on Eustachian tube function can be treated with
medicines. Therefore, the investigators also plan to evaluate enrolled persons for those
conditions. It is expected that if the results of the standard Eustachian tube function
tests can be explained by the anatomy of the back of the nose and Eustachian tube, the
functional anatomy (movements during swallowing etc) of the Eustachian tube or the presence
of allergy and or/acid reflux disease, new medical and/or surgical treatments can be
developed to improve Eustachian tube function and "cure" or treat the associated middle-ear
diseases.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 18 years of age and older - at least one functioning tympanostomy tube Exclusion Criteria: - any diagnosed cancer - otitis onset attributable to barotrauma (eg, hyperbaric oxygen treatment) - known vestibular/inner ear pathology who may incur dizzy or vertigo symptoms as a result of increase in middle ear pressure - history of ossicular chain reconstruction - known hypersensitivity to topical medicines (lidocaine, oxymetazoline) - severe nasal obstruction |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Middle Ear Physiology Laboratory, Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | serum IgE titer | results of blood test for allergy | Visit 1 | No |
Other | GERD survey | results of questions on gastroesophageal reflux | Visit 1 | No |
Primary | Eustachian tube function | manometric tests of ET function | Visit 1 | No |
Secondary | results of videoendoscopic exam | endoscopic examination of ET during various maneuvers | Visit 1 | No |
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