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临床试验/NCT01332825
NCT01332825已完成不适用

cAMP Levels in the Nose

University of Washington1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
UPSIT

研究概览

简要总结

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.

详细描述

The investigators will recruit 40 subjects: 10 with olfactory dysfunction and 30 with normal olfaction. The normal olfaction group will be randomized (15-15)to 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 test)and 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal olfactory function cohort:
  • •self-reported normal smell function
  • •age greater than 18 years
  • •Olfactory dysfunction cohort:
  • •ICD9 diagnostic code for olfactory dysfunction
  • •idiopathic olfactory dysfunction
  • •age greater than 18 years

排除标准

  • •allergy to lidocaine
  • •active upper respiratory infection
  • •previous nasal or sinus surgery
  • •current tobacco use
  • •unable to give consent due to language barrier, cognitive or medical issues

研究组 & 干预措施

olfactory dysfunction

No Intervention

subjects diagnosed with olfactory dysfunction

normal olfaction, no saline

No Intervention

no smell dysfunction, not randomized to saline nasal irrigation for 7 days

normal olfaction

Other

normal olfaction, randomized to saline nasal irrigation for 7 days

干预措施: saline nasal irrigation (Other)

结局指标

主要结局

UPSIT

时间窗: 7 days

validated, scratch and sniff smell identification test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Greg Davis

Assistant Professor

University of Washington

研究点 (1)

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