NCT00694421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

June 5, 2008

Last Update Submit

November 2, 2016

Conditions

Upper Respiratory Infection

Keywords

otitisEustachian tubevirusMiddle ear disease

Outcome Measures

Primary Outcomes (1)

  • Eustachian tube function

    3 months (adults), 6 months (children)

Study Arms (2)

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

Eligibility Criteria

Age2 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Membership in one of the two identified source populations

You may qualify if:

  • Participating/participated in one of the two identified studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Research Center Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsOtitisVirus Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • William J Doyle, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • J Douglas Swarts, PhD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research, ENT Department of CHP

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 10, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2011

Study Completion

May 1, 2012

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)