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

Sponsor
Cuneyt M. Alper (Other)
Overall Status
Completed
CT.gov ID
NCT00694421
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
139
Enrollment
1
Location
52
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Jan 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    May 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Eustachian tube function [3 months (adults), 6 months (children)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 54 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    • Principal Investigator: William J Doyle, PhD, University of Pittsburgh
    • Study Director: J Douglas Swarts, PhD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cuneyt M. Alper, Director of Research, ENT Department of CHP, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT00694421
    Other Study ID Numbers:
    • 0607007
    • P50DC007667
    First Posted:
    Jun 10, 2008
    Last Update Posted:
    Nov 4, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cuneyt M. Alper, Director of Research, ENT Department of CHP, University of Pittsburgh
    otitis
    Eustachian tube
    virus
    Middle ear disease
    Additional relevant MeSH terms:
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Nov 4, 2016