Eustachian Tube Testing in a Pressure Chamber -- Validation Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00694486
First received: June 5, 2008
Last updated: September 8, 2010
Last verified: September 2010
  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 Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • Eustachian tube function testing results [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694486

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

No publications provided

Responsible Party: William J. Doyle, PhD, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT00694486     History of Changes
Other Study ID Numbers: PRO07070157, 1P50DC007667
Study First Received: June 5, 2008
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
otitis
Eustachian tube function
Normal middle ear status

ClinicalTrials.gov processed this record on October 30, 2014