Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Genetics of Middle Ear Disease

This study has been completed.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Margaretha Casselbrant, Children's Hospital of Pittsburgh Identifier:
First received: January 12, 2007
Last updated: November 11, 2011
Last verified: November 2011
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.

Otitis Media

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Epidemiology of Otitis Media

Resource links provided by NLM:

Further study details as provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:

Biospecimen Retention:   Samples With DNA
Blood samples, DNA

Enrollment: 2121
Study Start Date: July 2002
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Families with 2 or more full sibs who had tympanostomy tubes inserted

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00422136

United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Children's Hospital of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Margaretha L Casselbrant, MD, PhD Children's Hospital of Pittsburgh
  More Information

Responsible Party: Margaretha Casselbrant, Principal Investigator, Children's Hospital of Pittsburgh Identifier: NCT00422136     History of Changes
Other Study ID Numbers: R01DC005630 ( US NIH Grant/Contract Award Number )
Study First Received: January 12, 2007
Last Updated: November 11, 2011

Keywords provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:
middle ear

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases processed this record on May 25, 2017