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Completed

NCT Number: NCT00694486

Eustachian Tube Testing in a Pressure Chamber -- Validation Study

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.

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Key information

Conditions

Otitis Ear Diseases Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Eustachian tube function testing results

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Eustachian Tube Testing in a Pressure Chamber -- Validation

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2008
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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