Eustachian Tube Testing in a Pressure Chamber -- Validation Study

Otitis Clinical Trial

Official title:

Eustachian Tube Testing in a Pressure Chamber -- Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694486
• Other study ID #: PRO07070157
• Secondary ID: 1P50DC007667
• Status: Completed
• Start date: January 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otitis

Locations

Country	Name	City	State
United States	ENT Research Center Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eustachian tube function testing results		up to 3 months