NCT00797004

Brief Summary

The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system. The specific aims are:

  • to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients
  • to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An organotypic culture system for human tissue has been established to optimize the electrical signal acquisition.
  • to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function
  • to correlate the EOG findings with pre-operative testing of human olfactory function.
  • to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

November 21, 2008

Last Update Submit

June 27, 2012

Conditions

Keywords

olfactory dysfunction

Study Arms (1)

endoscopic sinus procedure candidates

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

surgical patients from the UW Otolaryngology - Head and Neck surgery clinic

You may qualify if:

  • over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks

You may not qualify if:

  • unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Lim JH, Davis GE, Rue TC, Storm DR. Human sinonasal explant system for testing cytotoxicity of intranasal agents. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):63-8. doi: 10.1002/alr.20110. Epub 2011 Dec 13.

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Greg E Davis, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations