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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01976429
First received: October 18, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 regularly 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.


Condition Intervention
Middle-ear Barotrauma
Other: flight/diving simulation
Other: ET function testing at ambient pressure
Other: nasal video-endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 2

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • ET function testing as a predictor of failed flight/dive simulations [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    various ET function test parameters will be analyzed for their ability to predict development of symptoms during flight/dive simulations


Secondary Outcome Measures:
  • nasal video-endoscopy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    In subjects who entered with a history of symptoms during flight/diving, the nose, nasopharynx and Eustachian tube orifices will be examined to determine if there is a gross anatomical basis for the symptoms.


Estimated Enrollment: 210
Study Start Date: October 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
asymptomatic on flight/dive
individuals who experience no middle-ear problems on flying or diving
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
symptomatic on flying/diving
individuals who have experienced middle-ear problems on flying or diving
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • bilaterally intact tympanic membranes
  • frequent flyer or diver with middle-ear symptoms
  • frequent flyer or diver without middle-ear symptoms (controls)
  • generally good health
  • no recent history of non-activity related otitis media

Exclusion Criteria:

  • existing middle-ear disease
  • allergic rhinitis symptoms or "cold" on day of testing
  • syndrome predisposing to otitis media
  • history of ossicular reconstruction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976429

Contacts
Contact: Julie Banks, BS 412-692-3595 juliane.banks@chp.edu

Locations
United States, Pennsylvania
University of Pittsburgh Middle Ear Physiology Laboratory Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sub-Investigator: Cuneyt M Alper, MD         
Principal Investigator: William J Doyle, PhD         
Sub-Investigator: Charles D Bluestone, MD         
Sub-Investigator: Margaretha L Casselbrant, MD, PhD         
Sub-Investigator: Ellen M Mandel, MD         
Sub-Investigator: Douglas J Swarts, PhD         
Sub-Investigator: Miriam S Teixeira, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: William J Doyle, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: William J. Doyle, Professor, Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01976429     History of Changes
Other Study ID Numbers: PRO13040671-2, 2P50DC007667
Study First Received: October 18, 2013
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
barotrauma
barotitis
middle ear
flying
diving
Eustachian tube

Additional relevant MeSH terms:
Barotrauma
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014