NCT00422851

Brief Summary

This study will determine if gas can pass between the environment and the middle ear by way of the eardrum. This route of gas exchange was observed in animals but has not been studied in humans. If gas exchange across the eardrum is documented and the rate is sufficiently high, this can help explain certain past observations such as why middle ear pressure does not change very much in some children and adults when they have a cold or flu. The investigators also expect that the rate of gas exchange across the eardrum will depend on whether or not the eardrum has scarred or abnormally thin regions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

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

January 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

First QC Date

January 12, 2007

Last Update Submit

November 8, 2017

Conditions

Healthy

Keywords

otitisgas diffusionEustachian tubetympanic membrane

Study Arms (3)

1

Normal tympanic membrane

2

tympanosclerosis

3

dimeric (atrophic)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adults 18-50 years old with at least one intact and effusion-free middle ear

You may qualify if:

  • years old
  • at least one intact and effusion-free middle ear

You may not qualify if:

  • bilateral otitis media
  • unable to remain relaxed and quiet for up to 2 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • William Doyle, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • J. Douglas Swarts, PhD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 17, 2007

Study Start

June 1, 2007

Study Completion

February 1, 2009

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(1)