Eustachian Tube Testing in a Pressure Chamber -- Validation Study

NCT ID: NCT00694486

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Otitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Healthy adult volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William J Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1P50DC007667

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO07070157

Identifier Type: -

Identifier Source: org_study_id

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