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

Sinusitis Clinical Trial

— cAMP  

Official title:

Olfactory Dysfunction of Rhinosinusitis - cAMP/Calcium Signaling Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970190
• Other study ID #: 36534-B
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: December 10, 2014
• Start date: August 2009
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sinusitis

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Greg Davis

Country where clinical trial is conducted

United States,