An observational study in Healthy, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by University of Pittsburgh · Observational
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.
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.
247 studies on the registry are indexed under Otitis; 21 are open to participants now.
This study's enrollment of 45 is below the median of 140 across 63 observational studies indexed under Otitis.
Browse Otitis studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults 18-50 years old with at least one intact and effusion-free middle ear
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Exclusion Criteria:
Normal tympanic membrane
tympanosclerosis
dimeric (atrophic)
The record gives a start of Jun 2007 and a completion of Feb 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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