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

NCT ID: NCT00970190

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sinusitis

Keywords

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sinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greg Davis

OTHER

Sponsor Role lead

Responsible Party

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Greg Davis

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Greg E Davis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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36534-B

Identifier Type: -

Identifier Source: org_study_id