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

Upper Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694421
• Other study ID #: 0607007
• Secondary ID: P50DC007667
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: November 2, 2016
• Start date: January 2008
• Est. completion date: May 2012

Study information

• Verified date: November 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 54 Years

Eligibility

Inclusion Criteria:

• Participating/participated in one of the two identified studies

Exclusion Criteria:

• No longer meet inclusion/exclusion criteria of parent studies

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infection

Locations

Country	Name	City	State
United States	ENT Research Center Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cuneyt M. Alper	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eustachian tube function		3 months (adults), 6 months (children)	No