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Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c

NCT ID: NCT00422851

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Middle-ear (ME) pressure is a measure of the number of contained gas moles, and processes that addd or remove gas moles from the relatively fixed volume ME cavity change its pressure. Experimental results from animal studies document significant gas exchange across the tympanic membrane and if confirmed for humans may explain some of the paradoxical findings for children with poor Eustachian tube function such as the preservation of an aerated ME when the normal routes of gas supply are disrupted. This study measures the rates of reactive and inert gas exchange across the adult tympanic membrane with and without structural abnormalities and determines if these transfers are purely diffusive phenomena. The resulting data will be used to develop species-specific rate-constants that will be used as parameters in modeling ME pressure regulation.

Conditions

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Healthy

Keywords

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otitis gas diffusion Eustachian tube tympanic membrane

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Normal tympanic membrane

No interventions assigned to this group

2

tympanosclerosis

No interventions assigned to this group

3

dimeric (atrophic)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* bilateral otitis media
* unable to remain relaxed and quiet for up to 2 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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J. Douglas Swarts

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

J. Douglas Swarts, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NIH P50DC007667

Identifier Type: -

Identifier Source: secondary_id

0609093

Identifier Type: -

Identifier Source: org_study_id