Functional Manifestations of Pressure Changes in the Middle Ear System

Study Overview
=================
Brief Summary
-----------------
This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits, 1 for screening to determine eligibility and 1 for the fMRI. This study will help to understand how the middle ear system is controlled, which may have an impact on how people with middle ear disease are treated.

Detailed Description
-----------------
Otitis media is a ubiquitous disease in young children which can persist through adolescence, and arise or recur in adults. A consequence of an infection and/or Eustachian tube dysfunction, it manifests as an effusion that disrupts the normal impedance matching function of tympanic membrane-ossicular chain system. Eustachian tube dysfunction prevents the equilibration of middle ear pressures and drainage of the accumulated effusion. It is thought that middle ear status modulates the function of the Eustachian tube via afferent signals processed centrally resulting in changes in its tonus or muscular function. This pilot study of right-handed 21-35 year olds of either sex will validate a published fMRI method for visualizing cortical brain activation in response to external ear canal pressure changes (N=5). The outcome measure is intensity changes of the cortex associated with applied stimuli.

Official Title
-----------------
Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study

Conditions
-----------------
Middle-ear Function

Intervention / Treatment
-----------------
* Other: changing ear canal pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21-35 years of age right-handed Exclusion Criteria: left-handedness or ambidexterity fMRI safety reasons (ferromagnetic material in their bodies, epilepsy, claustrophobia history of middle ear/tympanic membrane surgery (tympanostomy tubes) abnormal otoscopic findings and/or tympanometry on physical exam pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteers<br>healthy volunteers undergo pressure changes in ear canal | Other: changing ear canal pressure<br>* ear canal pressure changes: pressure varied from +/-40 decapascals<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in brain activation during pressure changes | Subjects will have fMRIs while pressure is varied in the right ear (+/-40 decapascals). Changes in brain activation during pressure changes will be measured by fMRI during approximately 1 hour scanning time. | 1 hour (Visit 2, during fMRI) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
middle ear, Eustachian tube, fMRI