Study Results
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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COMPLETED
23 participants
OBSERVATIONAL
2008-11-30
2010-09-30
Brief Summary
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The specific aims are:
* to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients
* to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An organotypic culture system for human tissue has been established to optimize the electrical signal acquisition.
* to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function
* to correlate the EOG findings with pre-operative testing of human olfactory function.
* to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.
Detailed Description
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Subjects will sign consent and complete a subjective smell test (UPSIT--University of Pennsylvania Smell Identification Test), and the SNOT-20 (Sinonasal Outcome Test-20)
During their surgery, subjects will have two to four pieces of normally discarded tissue preserved for the study. Subjects will also have two to four pieces of healthy tissue removed (total size approximately that of a pencil eraser tip)depending on the type of surgery involved. The following procedures will be performed on these tissues:
* immunocytochemistry utilizing antibodies to AC3 and Golf to determine the patterns and levels of expression of these proteins
* two odorants, isoamyl acetate and citralva, to elicit odorant-induced activity from the human olfactory sensory neurons. The tissue will also be subjected to two putative human pheromones: 4,16-androstadiene-3-ol and 1,3,5(10),16-estrateraen-3-ol.
* application of six commonly used intranasal agents: 0.9% saline, 1:1000,000 epinephrine, 0.05% oxymetazoline, 1% lidocaine, Zicam (0.12% zinc gluconate) and Nasocort AQ (triamcinolone acetate).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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endoscopic sinus procedure candidates
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Greg Davis
OTHER
Responsible Party
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Greg Davis
Assistant Professor
Principal Investigators
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Greg E Davis, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Lim JH, Davis GE, Rue TC, Storm DR. Human sinonasal explant system for testing cytotoxicity of intranasal agents. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):63-8. doi: 10.1002/alr.20110. Epub 2011 Dec 13.
Other Identifiers
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35031-B
Identifier Type: -
Identifier Source: org_study_id