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Genetics of Middle Ear Disease

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ClinicalTrials.gov Identifier: NCT00422136
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

January 12, 2007
January 15, 2007
November 14, 2017
July 2002
July 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00422136 on ClinicalTrials.gov Archive Site
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Genetics of Middle Ear Disease
Genetic Epidemiology of Otitis Media
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.
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.
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Blood samples, DNA
Non-Probability Sample
Families with 2 or more full sibs who had tympanostomy tubes inserted
Otitis Media
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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: 10.1186/1471-2350-10-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2009
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
R01DC005630( U.S. NIH Grant/Contract )
R01DC005630 ( U.S. NIH Grant/Contract )
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Margaretha L. Casselbrant, University of Pittsburgh
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Margaretha L Casselbrant, MD, PhD University of Pittsburgh
University of Pittsburgh
November 2017