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

NCT ID: NCT00694421

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Upper Respiratory Infection

Keywords

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otitis Eustachian tube virus Middle ear disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

adults who participate in study, "Social and Psychological Risks for Infectious Disease" here at Children's Hospital of Pittsburgh

No interventions assigned to this group

2

children 2-6 years who participate in "Role of Virus and Genetic Susceptibility" study here at Children's Hospital of Pittsburgh

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participating/participated in one of the two identified studies
Minimum Eligible Age

2 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Cuneyt M. Alper

OTHER

Sponsor Role lead

Responsible Party

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Cuneyt M. Alper

Director of Research, ENT Department of CHP

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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William J Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

J Douglas Swarts, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P50DC007667

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0607007

Identifier Type: -

Identifier Source: org_study_id