Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults
Condition: Eustachian Tube Dysfunction; Chronic Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      This study requires a single visit to the Middle Ear Physiology Laboratory (MEPL) located on
      the first floor of the Oakland Medical Building (3420 Fifth Avenue in Oakland, Pittsburgh,
      PA). Adjacent parking attached to that building is available. The total time of the visit
      should be about 2 hours.

      If the subject is eligible and signs informed consent to participate in the study, a series
      of questions regarding past history of ear disease will be asked as well as whether or not a
      subject has any of several risk factors that makes people more likely to develop otitis media
      with effusion and other ear diseases. The subject will also complete a short questionnaire
      that asks questions about whether or not they have symptoms consistent with acid reflux
      disease. Then, a blood sample (about 2/3 of a tablespoon) will be taken from an arm vein and
      sent to a laboratory for assay of chemicals associated with allergic diseases. These
      procedures should take about 30 minutes to complete.

      Then, the subject's Eustachian tube function will be tested in the ear/ears that have open
      tympanostomy tubes in the eardrum. For these tests, the subject will be seated comfortably in
      a chair and a soft rubber tube will be put partway into their ear canal. This tube is
      attached to a machine that can change the pressure in the ear and measure the pressure at
      which the Eustachian tube opens and closes, as well as how easily air flows through the
      Eustachian tube and how easily the subject can open their Eustachian tube during swallowing.
      These tests only require that the subject not pull the ear plug from their ear and perform
      certain procedures designed to open their Eustachian tube such as swallowing with an open and
      pinched nose, blowing against a closed nose and deep breathing. The total time for testing is
      about 20 minutes per ear.

      Then, a study doctor will apply topical medicines by spray and cotton balls to the inside of
      the nose to decrease any swelling and numb the nose (4% Lidocaine and 0.05% Oxymetazoline
      mixed in 1:1 proportion). After a short break of about 20 minutes to allow time for these
      medicines to work, the study doctor will choose which side of the subject's nose is most open
      and will introduce a small video telescope (called an endoscope) into that side of the nose
      and move it to the back of the nose. This will allow him/her to see the back of the nose and
      the Eustachian tubes. He/she will focus the endoscope on the Eustachian tubes and will record
      video images of the back of the nose, the Eustachian tubes at rest and the movements of the
      Eustachian tubes while the subject swallows, yawns, repeats an "O" sound, repeats a "K" sound
      and moves their jaw. The subject will be able to see the movements of the Eustachian tube on
      a monitor while performing these procedures. This procedure should take about 40 minutes to
      complete.

      After this test, the study is complete.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        adults with tympanostomy tube(s) for chronic otitis media and/or eustachian tube
        dysfunction
      
Keywords: otitis media; Eustachian tube; allergy; gastroesophageal reflux; tympanostomy tube