Functional Manifestations of Pressure Changes in the Middle Ear System

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

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.

Study Overview

• Status: Completed
• Conditions: Middle-ear Function
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Douglas Swarts, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: fMRI; Eustachian tube; middle ear
• Other Study ID Numbers: PRO13030623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO