Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3

Stopped early · Early Phase 1

Conditions studied: Middle-ear Function

In brief

This is a study to determine if there are reflexes that detect changes in eardrum position or in the pressure of middle-ear gases and respond with changes in the ease by which the Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles that surround the tube. If the Eustachian tube does not open frequently enough, the pressure in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its pressure. There is some evidence that the changes in eardrum position and middle-ear pressure when the Eustachian tube does not open frequently enough can be detected by the brain that, in turn, sends signals to the Eustachian tube and its muscles to make Eustachian tube opening easier. In this study, we will test this possibility. Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and out, apply different pressures to the middle ear, or change the composition of the gases in the middle ear while we measure how difficult it is to open the Eustachian tube by increasing middle-ear pressure or by measuring the "readiness" of the Eustachian tube muscles to contract and open the tube.

Key facts

Study ID: NCT01925495
Run by: Cuneyt M. Alper
People needed: 32
Starts: 2016-12-02
Expected to finish: 2019-01-17
Last updated by the study team: 2019-05-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Otherwise healthy adults aged 18 to 50 years, inclusive
No history of significant ME disease
No history of past ME surgeries
Able to comprehend study risks and provide written Informed Consent

You may not qualify if…

Have any chronic health problem
Have ME fluid or otitis media (OM)at the time of presentation
Have drainage through the tympanostomy tube at the time of testing
Taking any prescription drug with the exception of those for birth control that would interfere with study per study MD
Have a known or suspected allergy/adverse reaction to any of the study drugs use to prepare the tympanic membrane for ventilation tube insertion or the nasopharynx for EMG needle insertion
Have a hearing threshold >15 dB or a >10 dB air-bone gap at any of the speech frequencies
Pregnant or nursing
Temporary exclusion: expected need for seasonal allergy med during study

Where it is running

Middle Ear Physiology Laboratory, University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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