Eustachian Tube Testing in a Pressure Chamber -- Validation Study

This study is currently recruiting participants.

Verified by Children's Hospital of Pittsburgh, June 2008

Sponsors and Collaborators:	Children's Hospital of Pittsburgh 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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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: 4 tests ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Healthy adult volunteers

Detailed Description:

We 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 illnesss 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

Contacts

Contact: James Seroky, MS	412-692-5463	james.seroky@chp.edu
Contact: Douglas Swarts, PhD	412-692-5463	dswarts@pitt.edu

Locations

United States, Pennsylvania
ENT Research Center Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: William J Doyle, PhD

Sponsors and Collaborators

Children's Hospital of Pittsburgh

National Institutes of Health (NIH)

More Information

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

Keywords provided by Children's Hospital of Pittsburgh:

otitis
Eustachian tube function
Normal middle ear status

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otitis
Ear Diseases

ClinicalTrials.gov processed this record on January 16, 2009