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

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ClinicalTrials.gov Identifier: NCT00694421
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):

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

Condition or disease
Upper Respiratory Infection

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.

Study Design

Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2
Study Start Date : January 2008
Primary Completion Date : October 2011
Study Completion Date : May 2012
Groups and Cohorts

adults who participate in study, "Social and Psychological Risks for Infectious Disease" here at Children's Hospital of Pittsburgh
children 2-6 years who participate in "Role of Virus and Genetic Susceptibility" study here at Children's Hospital of Pittsburgh

Outcome Measures

Primary Outcome Measures :
  1. Eustachian tube function [ Time Frame: 3 months (adults), 6 months (children) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 54 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Membership in one of the two identified source populations

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694421

United States, Pennsylvania
ENT Research Center Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Cuneyt M. Alper
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: William J Doyle, PhD University of Pittsburgh
Study Director: J Douglas Swarts, PhD University of Pittsburgh
More Information

Responsible Party: Cuneyt M. Alper, Director of Research, ENT Department of CHP, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00694421     History of Changes
Other Study ID Numbers: 0607007
P50DC007667 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cuneyt M. Alper, University of Pittsburgh:
Eustachian tube
Middle ear disease

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases