NCT01955486

Brief Summary

The purpose of this study is to gather more information on Eustachian tube function and middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function will be monitored at various chamber pressures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

4.5 years

First QC Date

September 27, 2013

Last Update Submit

August 4, 2019

Conditions

Middle-ear Function

Keywords

flight simulationmiddle earEustachian tube function

Outcome Measures

Primary Outcomes (1)

  • middle-ear pressures

    middle-ear pressure will be monitored continuously during experiment

    single visit

Secondary Outcomes (1)

  • Eustachian tube function

    single visit

Study Arms (1)

flight simulation

EXPERIMENTAL

flight simulation in pressure chamber

Other: flight simulation

Interventions

flight simulationOTHER
flight simulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults 18-50 years of age
  • have unilateral or bilateral holes in the eardrums/patent tympanostomy tubes
  • otherwise healthy
  • ability to read and comprehend English

You may not qualify if:

  • drainage through either tube or hole in the eardrum
  • cold or allergic rhinitis on presentation
  • syndrome predisposing to otitis media
  • history of ossicular reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Middle Ear Physiology Laboratory

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Cuneyt M Alper, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Otolaryngology

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 7, 2013

Study Start

October 1, 2013

Primary Completion

April 3, 2018

Study Completion

April 3, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)