Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01332825
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2011-04-07
Brief Title:
cAMP Cyclic Adenosine Monophosphate Levels in the Nose
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
cAMP Levels in the Nose
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the normal distribution of nasal tissue cathelicidin antimicrobial peptides cAMP levels in subjects with normal smell and subjects with smell dysfunction The investigators will also look at the effect of nasal saline irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting olfactory cilia The investigators hypothesize that nasal saline will have no effect on olfaction and will be inadequate to harvest olfactory cilia
Detailed Description:
The investigators will recruit 40 subjects 10 with olfactory dysfunction and 30 with normal olfaction The normal olfaction group will be randomized 15-15to either daily saline nasal irrigation for one week or no irrigation Normal olfaction subjects will be seen for two visits olfactory dysfunction for one All subjects will complete an UPSIT smell identification testand a co-morbidity form All subjects will have a brief nasal exam and then have nasal cells collected by means of a curette on one side and a cytobrush on the other All subjects will receive Afrin and lidocaine to improve visualization and for comfort during cell collection Subjects will then complete a Comfort Scale related to the methods of cell collection Normal olfaction subjects randomized to nasal irrigation will receive instructions on how to do it and the irrigation results will be collected for analysis along with the nasal cells At their return visit normal olfaction subjects will repeat the UPSIT and the comfort scale--all normal olfaction subjects will have a repeat cell collection Subjects randomized to nasal irrigation will also complete a transition scale which asks if they feel the irrigation made a difference in their sense of smell Subjects are compensated for time with a gift card
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None