Genetics of Middle Ear Disease

The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT Research Center, Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

About this study

Using the twin study approach, the investigators demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component. The point estimate of heritability of time with MEE was 0.73. While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown. The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power. Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. A blood sample will be obtained from each subject for genotyping.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

families: 2 or more full sibs who had tympanostomy tubes inserted

Exclusion criteria

major congenital malformations
medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations
cared for in the Intensive Care Unit as neonate
been on assisted ventilation
known sensorineural hearing loss

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Genetic Epidemiology of Otitis Media

Important dates

Study start: 2002
Primary completion: 2007
Study completion: 2009
First posted: Jan 15, 2007
Registry last updated: Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed