Olfactory Dysfunction of Rhinosinusitis - Cyclic Adenosine Monophosphate (cAMP)/Calcium Signaling Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Observational Model: Cohort Time Perspective: 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:
- endoscopic sinus surgery for chronic sinusitis
- endoscopic transnasal approach to the pituitary for pituitary tumor removal
- endoscopic inferior turbinectomy or septoplasty for nasal congestion
- endoscopic repair of cerebrospinal fluid (CSF) leaks
Exclusion Criteria:
- Subjects are excluded if they are unable to give informed consent or unable to complete self-administered questionnaires due to English language barrier, cognitive impairment, or severe medical conditions
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
No publications provided
| Responsible Party: | Greg Davis, Assistant Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00970190 History of Changes |
| Other Study ID Numbers: | 36534-B |
| Study First Received: | August 31, 2009 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
sinusitis |
Additional relevant MeSH terms:
|
Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013