Functional Manifestations of Pressure Changes in the Middle Ear System

NCT ID: NCT01932736

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Middle-ear Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

healthy volunteers

healthy volunteers undergo pressure changes in ear canal

Group Type: EXPERIMENTAL

changing ear canal pressure

Intervention Type: OTHER

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

Interventions

changing ear canal pressure

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

J. Douglas Swarts

Research Associate Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Swarts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO13030623

Identifier Type: -

Identifier Source: org_study_id