Genetics of Middle Ear Disease

Completed

• Conditions: Otitis Media

• Registration Number: NCT00422136
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Primary Completion: 2007-07
• Study Completion: 2009-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

ENT Research Center, Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States