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Completed

NCT Number: NCT01932736

Functional Manifestations of Pressure Changes in the Middle Ear System

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.

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Key information

Conditions

Middle-ear Function

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

changing ear canal pressure

Other

ear canal pressure changes: pressure varied from +/-40 decapascals

Primary outcomes

  1. changes in brain activation during pressure changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Aug 30, 2013
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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