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Functional Manifestations of Pressure Changes in the Middle Ear System

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01932736
Enrollment
5
Registered
2013-08-30
Start date
2013-08-31
Completion date
2016-04-30
Last updated
2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle-ear Function

Keywords

middle ear, Eustachian tube, fMRI

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.

Interventions

OTHERchanging ear canal pressure

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

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes in brain activation during pressure changes1 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026