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Gas Supply, Demand and Middle Ear Gas Balance -- Fly/Dive Simulation

NCT01976429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-08-07

No results posted yet for this study

Summary

This study will determine if newly developed and more standard tests of Eustachian tube function can identify those persons who have ear pain (barotrauma) or develop middle-ear inflammation and/or fluid (barotitis) when they are exposed to rapid changes in air pressure as, for example, during airplane flights or scuba diving. Up to 150 adults and children (10-50 years old) who fly or dive at least 1-2 times and experience ear pain or develop middle-ear fluid during those activities and approximately 60 adults and children who fly or dive but do not experience these problems will undergo Eustachian tube function testing during simulated flight and diving.

Conditions

  • Middle-ear Barotrauma

Interventions

OTHER

flight/diving simulation

measurement of ET function during simulated flight/diving in pressure chamber

OTHER

ET function testing at ambient pressure

ET function testing at ambient pressure using sonometry, tubomonometry, 9-step test, maneuver sequence

OTHER

nasal video-endoscopy

examination of nose, nasopharynx,and Eustachian tube orifice

Sponsors & Collaborators

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

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Cuneyt M Alper, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-02
Primary Completion
2018-12-04
Completion
2018-12-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976429 on ClinicalTrials.gov