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| Sponsor: | University of Washington |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00970190 |
Purpose
The study examines the biochemistry underlying human olfaction in both normal and diseased states.
The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using calcium imaging and 4. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using "smell-chip" technology.
| Condition |
|---|
|
Sinusitis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Olfactory Dysfunction of Rhinosinusitis - cAMP/Calcium Signaling Study |
Samples consist of discarded tissue resulting from the following clinical procedures: endoscopic sinus surgery for chronic sinusitis, endoscopic transnasal approach to the pituitary for pituitary tumor removal, endoscopic inferior turbinectomy or septoplasty for nasal congestion and endoscopic repair of CSF leaks. Samples will only be retained for 1 year post-surgery and then destroyed.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Subject will be recruited from those scheduled to have endoscopic sinus surgery and similar procedures. This study uses the tissue that would normally be discarded during the surgical process. The tissue is cultured and frozen for purposes of the following testing:
odor detection and signal transduction, cyclic adenosine monophosphate and odor detection, the role of cAMP in olfactory dysfunction, and pheromone detection.
Only tissue that would normally be discarded during the course of the surgery will be used. The study does not interfere with or change any clinical care.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients presenting to the University of Washington Rhinology Clinic for evaluation of sinus problems
Inclusion Criteria:
Subjects will be 18 years old and over and scheduled for one of the following:
Exclusion Criteria:
Contacts and Locations| Contact: Greg E Davis, MD, MPH | 206-543-5230 | gedavis@u.washington.edu |
| Contact: Carolyn J Bea, BS | 206-744-1848 | cbea@u.washington.edu |
| United States, Washington | |
| University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: Greg E Davis, MD, MPH | |
| Principal Investigator: | Greg E Davis, MD, MPH | University of Washington |
More Information
| Responsible Party: | University of Washington Medical Center ( Greg Davis, MD, MPH ) |
| Study ID Numbers: | 36534-B |
| Study First Received: | August 31, 2009 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00970190 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
sinusitis |
|
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Paranasal Sinus Diseases Sinusitis Nose Diseases |
