Functional Manifestations of Pressure Changes in the Middle Ear System

Not Applicable

Completed

• Conditions: Middle-ear Function
• Interventions: Other: changing ear canal pressure

• Registration Number: NCT01932736
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2014-04
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 21-35 years of age
• right-handed

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy volunteers	changing ear canal pressure	healthy volunteers undergo pressure changes in ear canal

Primary Outcome Measures

Name	Time	Method
changes in brain activation during pressure changes	1 hour (Visit 2, during fMRI)	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.

Trial Locations

Locations (1)

Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States