Clinical Trial: Gas Supply, Demand and Middle Ear Gas Balance -- Fly/Dive Simulation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 2

Brief Summary: This study will determine if newly developed and more standard tests of Eustachian tube function can identify those persons who have ear pain (barotrauma) or develop middle-ear inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure as, for example, during airplane flights or scuba diving. Up to 150 adults and children (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop middle-ear fluid during those activities and approximately 60 adults and children who fly or dive but do not experience these problems will undergo Eustachian tube function testing during simulated flight and diving.

Detailed Summary:

Subjects will be recruited who only experience symptoms or present signs interpretable as Eustachian (ET) dysfunction (ETD) when exposed to rapid changes in ambient pressure as, for example, during flights in airplanes (in the absence of a concurrent cold/active nasal allergy) or during free and tanked diving. In general, subjects presenting to physicians with these conditions are diagnosed with poor ET function (ETF) based solely on symptom/sign presentation. However, it is not known how to identify those persons who will experience these symptoms/signs at a future time which is the goal of this study or how to prevent those presentations in susceptible individuals. To calibrate the test protocol, 20 subjects/age ranges of 10-19, 20-29 and 30-50 years (total=60 control subjects) who are in good health, fly and/or dive frequently but report no ear-related problems on ascent or descent, will be recruited. One hundred fifty symptomatic subjects in general good health aged 10 to 50 years with the lower age limit chosen to assure good communication between the subject and investigators, will also be recruited. These and the control subjects will have intact tympanic membranes since subjects with non-intact tympanic membranes do not experience barotrauma but maintain ambient middle-ear (ME) pressures throughout a flight.

A general history with a focus on the specific symptomatic complaints and the maneuvers performed in attempting to relieve any otologic symptoms during airplane flight/diving will be taken, an ear, nose and throat (ENT) exam, including tympanometry, done to confirm intact tympanic membranes and a disease-free ME and nasal exam done to rule out concurrent nasal inflammation. Then, sonotubometry, the 9-step test, tubomanometry and the "sniffing", Valsalva and Toynbee maneuvers will be done to establish baseline ETF. If a patulous (by observation of syn
Sponsor: University of Pittsburgh

Current Primary Outcome: ET function testing as a predictor of failed flight/dive simulations [ Time Frame: Day 1 ]

various ET function test parameters will be analyzed for their ability to predict development of symptoms during flight/dive simulations


Original Primary Outcome: Same as current

Current Secondary Outcome: nasal video-endoscopy [ Time Frame: Day 1 ]

In subjects who entered with a history of symptoms during flight/diving, the nose, nasopharynx and Eustachian tube orifices will be examined to determine if there is a gross anatomical basis for the symptoms.


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: October 18, 2013
Date Started: October 2013
Date Completion: June 2018
Last Updated: November 2, 2016
Last Verified: November 2016