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

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ClinicalTrials.gov Identifier: NCT00970190
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Sinusitis

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.


Study Design

Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Olfactory Dysfunction of Rhinosinusitis - cAMP/Calcium Signaling Study
Study Start Date : August 2009
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Sinusitis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970190


Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Greg Davis
Investigators
Principal Investigator: Greg E Davis, MD, MPH University of Washington
More Information

Responsible Party: Greg Davis, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00970190     History of Changes
Other Study ID Numbers: 36534-B
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Greg Davis, University of Washington:
sinusitis

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