cAMP Levels in the Nose
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
subjects diagnosed with olfactory dysfunction
normal olfaction, no saline
no smell dysfunction, not randomized to saline nasal irrigation for 7 days
normal olfaction
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
Greg Davis
Assistant Professor
University of Washington
