Genetics of Middle Ear Disease

Otitis Media Clinical Trial

Official title:

Genetic Epidemiology of Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422136
• Other study ID #: R01DC005630
• Secondary ID: R01DC005630
• Status: Completed
• Phase: N/A
• First received: January 12, 2007
• Last updated: November 10, 2017
• Start date: July 2002
• Est. completion date: July 2009

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2121
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Locations

Country	Name	City	State
United States	ENT Research Center, Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Casselbrant ML, Mandel EM, Jung J, Ferrell RE, Tekely K, Szatkiewicz JP, Ray A, Weeks DE. Otitis media: a genome-wide linkage scan with evidence of susceptibility loci within the 17q12 and 10q22.3 regions. BMC Med Genet. 2009 Sep 3;10:85. doi: 10.1186/147 — View Citation