Functional Manifestations of Pressure Changes in the Middle Ear System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
J. Douglas Swarts, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01932736
First received: August 9, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention
Middle-ear Function
Other: changing ear canal pressure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • changes in brain activation during pressure changes [ Time Frame: 1 hour (Visit 2, during fMRI) ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: August 2013
Estimated Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy volunteers
healthy volunteers
Other: changing ear canal pressure
ear canal pressure changes: pressure varied from +/-40 decapascals

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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 9, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
middle ear
Eustachian tube
fMRI

ClinicalTrials.gov processed this record on October 29, 2014