Eustachian Tube Testing in a Pressure Chamber -- Validation Study

This study has been completed.

First Received on June 5, 2008. Last Updated on September 8, 2010 History of Changes

Sponsor:	Children's Hospital of Pittsburgh
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00694486

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

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

National Institutes of Health (NIH)

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

Additional relevant MeSH terms:

Otitis
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012