跳至主要内容
临床试验/NCT00694421
NCT00694421已完成不适用

Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2

Cuneyt M. Alper1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
1
主要终点
Eustachian tube function

研究概览

简要总结

This study will test the hypothesis that constitutionally poorer Eustachian tube function predisposes to middle-ear pathology during a viral upper respiratory infection.

详细描述

The most well supported immediate cause of Otitis media (OM) is a pre-existing or concurrent viral upper respiratory tract infection (vURI). However, not all vURI episodes cause OM and a variety of predisposing factors has been suggested to explain this selectivity. Based on our preliminary work using a model of experimental viral infections in adults, we hypothesize that the constitutional efficiency of the Eustachian tube (ET) to supply the middle ear (ME) with gas and thereby stabilize ME pressure at near ambient is a primary risk factor for OM during vURI. Here, we test the hypothesis that constitutionally poorer ET function (F) predisposes to ME pathology during a vURI. Specifically, we will use ETF testing protocols relevant to the pressure-chamber to evaluate constitutional ETF in ≈ 160 susceptible, adult volunteers who will be exposed to rhinovirus as part of our funded study entitled "Social and Psychological Risks for Infectious Disease" (PI: S. Cohen, PI: CHP subcontract: WJ Doyle) and document the ETF and ME responses to infection over a 5-day post-exposure, cloister period.

Also, using protocols relevant to the pressure-chamber, we will evaluate constitutional ETF in 80 children who will be enrolled into our funded study entitled "Role of Virus and Genetic Susceptibility in Otitis Media" (PI: CM Alper) and followed for vURI and OM from October through April. From both data sets, we will extract measures of ETF efficiency and determine using logistic regression with appropriate control variables (e.g. demographic data etc) if a single or combination of ETF variables predicts an abnormal ME response in rhinovirus infected adults or OM during a rhinovirus cold in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 54 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participating/participated in one of the two identified studies

排除标准

  • No longer meet inclusion/exclusion criteria of parent studies

结局指标

主要结局

Eustachian tube function

时间窗: 3 months (adults), 6 months (children)

次要结局

未报告次要终点

研究者

发起方
Cuneyt M. Alper
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cuneyt M. Alper

Director of Research, ENT Department of CHP

University of Pittsburgh

研究点 (1)

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