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

Cuneyt M. Alper

Status: Completed

Conditions: Upper Respiratory Infection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00694421

P50DC007667 (U.S. NIH Grant/Contract)

0607007

Details and patient eligibility

About

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

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 2 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participating/participated in one of the two identified studies

Exclusion criteria

• No longer meet inclusion/exclusion criteria of parent studies

Trial design

139 participants in 2 patient groups

1

Description:

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

2

Description:

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