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Eustachian Tube Testing in a Pressure Chamber -- Validation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694486
First Posted: June 10, 2008
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

Condition
Otitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eustachian Tube Testing in a Pressure Chamber -- Validation

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Eustachian tube function testing results [ Time Frame: up to 3 months ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy adult volunteers

Detailed Description:
The investigators propose to introduce new test methods and protocols to our laboratory for better clinical characterization of Eustachian tube function in ears with intact TM's. These test will be done in a pressure-chamber and will use previously published and newly developed methods. Participation will require a minimum of 5 visits to the ENT Research Center, 1 for myringotomy (putting a small hole in the eardrum) and 4 for ETF testing. Hearing testing will be done at entry and exit; otoscopy (looking at the ears) and tympanometry (a test done with an earplug and varying pressures in the ear canal) are done at every visit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adults
Criteria

Inclusion Criteria:

  • >18 years old
  • Normal middle-ear status

Exclusion Criteria:

  • Chronic illness including asthma, pulmonary, or cardiac problems
  • Pregnancy
  • >10 dB hearing loss in any of the speech frequencies
  • Past history of sensitivity or allergic reaction to lidocaine or related compounds
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694486


Locations
United States, Pennsylvania
ENT Research Center Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
Principal Investigator: William J Doyle, PhD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00694486     History of Changes
Other Study ID Numbers: PRO07070157
1P50DC007667 ( U.S. NIH Grant/Contract )
First Submitted: June 5, 2008
First Posted: June 10, 2008
Last Update Posted: October 26, 2017
Last Verified: September 2010

Keywords provided by University of Pittsburgh:
otitis
Eustachian tube function
Normal middle ear status

Additional relevant MeSH terms:
Otitis
Ear Diseases
Otorhinolaryngologic Diseases