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Functional Manifestations of Pressure Changes in the Middle Ear System

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ClinicalTrials.gov Identifier: NCT01932736
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Middle-ear Function Other: changing ear canal pressure

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study
Study Start Date : August 2013
Primary Completion Date : April 2014
Study Completion Date : April 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: healthy volunteers
healthy volunteers undergo pressure changes in ear canal
Other: changing ear canal pressure
ear canal pressure changes: pressure varied from +/-40 decapascals


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932736


Locations
United States, Pennsylvania
Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Douglas Swarts, PhD University of Pittsburgh
More Information

Responsible Party: J. Douglas Swarts, Research Associate Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01932736     History of Changes
Other Study ID Numbers: PRO13030623
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by J. Douglas Swarts, University of Pittsburgh:
middle ear
Eustachian tube
fMRI