Clinical trial NCT00694421: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2
Official title: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Infection
Keywords: otitis
Eustachian tube
virus
Middle ear disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2008-06-10
Enrollment: 139
Sex: ALL
Minimum age (years): 2
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Membership in one of the two identified source populations

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.

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 criteria: Inclusion Criteria:

* Participating/participated in one of the two identified studies

Exclusion Criteria:

* No longer meet inclusion/exclusion criteria of parent studies

Primary outcomes:
measure: Eustachian tube function
timeFrame: 3 months (adults), 6 months (children)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Research Center Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William J Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: J Douglas Swarts, PhD
role: STUDY_DIRECTOR
References: