NCT01932736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

August 9, 2013

Last Update Submit

June 17, 2016

Conditions

Middle-ear Function

Keywords

middle earEustachian tubefMRI

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

healthy volunteers

EXPERIMENTAL

healthy volunteers undergo pressure changes in ear canal

Other: changing ear canal pressure

Interventions

changing ear canal pressureOTHER

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

healthy volunteers

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Douglas Swarts, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor of Otolaryngology

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)