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| Sponsor: | Children's Hospital of Pittsburgh |
|---|---|
| Collaborator: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by: | Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00422851 |
Purpose
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.
| Condition |
|---|
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Healthy |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c |
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2007 |
| Groups/Cohorts |
|---|
|
1
Normal tympanic membrane
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2
tympanosclerosis
|
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3
dimeric (atrophic)
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Adults 18-50 years old with at least one intact and effusion-free middle ear
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathy Tekely, RN | 412-692-5463 | |
| Contact: Ellen Mandel, MD | 412-692-5463 |
| United States, Pennsylvania | |
| ENT Research Center Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | William Doyle, PhD | Children's Hospital of Pittsburgh |
| Study Director: | J. Douglas Swarts, PhD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh School of Medicine ( William J. Doyle, PhD ) |
| Study ID Numbers: | 0609093, NIH P50DC007667 |
| Study First Received: | January 12, 2007 |
| Last Updated: | February 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00422851 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
otitis gas diffusion Eustachian tube tympanic membrane |