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Olfactory Dysfunction of Rhinosinusitis - Cyclic Adenosine Monophosphate (cAMP)/Calcium Signaling Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Greg Davis, University of Washington
ClinicalTrials.gov Identifier:
NCT00970190
First received: August 31, 2009
Last updated: December 11, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Biospecimen Retention:   Samples Without DNA

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: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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
Study Population

Patients presenting to the University of Washington Rhinology Clinic for evaluation of sinus problems

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970190

Contacts
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

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Greg E Davis, MD, MPH         
Sponsors and Collaborators
Greg Davis
Investigators
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: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
sinusitis

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 27, 2014