Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00797004
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
2008-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Olfactory Dysfunction of Rhinosinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096825', 'term': 'Rhinosinusitis'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2008-11-21', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['olfactory dysfunction'], 'conditions': ['Rhinosinusitis']}, 'referencesModule': {'references': [{'pmid': '22170775', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system.\n\nThe specific aims are:\n\n* to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients\n* 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.\n* to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function\n* to correlate the EOG findings with pre-operative testing of human olfactory function.\n* to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.', 'detailedDescription': 'This is a prospective cohort study. Subjects will be recruited from the group of patients at the University of Washington Otolaryngology-Head and Neck Surgery Clinic who will undergo endoscopic sinus surgery for chronic sinusitis and other disorders of the nasal cavity and sinuses.\n\nSubjects will sign consent and complete a subjective smell test (UPSIT--University of Pennsylvania Smell Identification Test), and the SNOT-20 (Sinonasal Outcome Test-20)\n\nDuring 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:\n\n* immunocytochemistry utilizing antibodies to AC3 and Golf to determine the patterns and levels of expression of these proteins\n* 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.\n* 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'surgical patients from the UW Otolaryngology - Head and Neck surgery clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks\n\nExclusion Criteria:\n\n* unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.'}, 'identificationModule': {'nctId': 'NCT00797004', 'acronym': 'ODOR', 'briefTitle': 'Olfactory Dysfunction of Rhinosinusitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Olfactory Dysfunction of Rhinosinusitis', 'orgStudyIdInfo': {'id': '35031-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endoscopic sinus procedure candidates'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Greg E Davis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greg Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Greg Davis', 'investigatorAffiliation': 'University of Washington'}}}}