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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00694421
First received: June 5, 2008
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition
Upper Respiratory Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Eustachian tube function [ Time Frame: 3 months (adults), 6 months (children) ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: January 2008
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
adults who participate in study, "Social and Psychological Risks for Infectious Disease" here at Children's Hospital of Pittsburgh
2
children 2-6 years who participate in "Role of Virus and Genetic Susceptibility" study here at Children's Hospital of Pittsburgh

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Membership in one of the two identified source populations

Criteria

Inclusion Criteria:

  • Participating/participated in one of the two identified studies

Exclusion Criteria:

  • No longer meet inclusion/exclusion criteria of parent studies
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00694421

Locations
United States, Pennsylvania
ENT Research Center Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: William J Doyle, PhD Children's Hospital of Pittsburgh
Study Director: J Douglas Swarts, PhD Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: William J. Doyle, Director of Research, ENT Department of CHP, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00694421     History of Changes
Other Study ID Numbers: 0605007, 1P50DC007667
Study First Received: June 5, 2008
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
otitis
Eustachian tube
virus
Middle ear disease

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014