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Trial record 13 of 1049 for:    "Ear Diseases"

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):

Study Description
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.

Condition or disease
Otitis Media

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 Design

Study Type : Observational
Actual Enrollment : 2121 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Epidemiology of Otitis Media
Study Start Date : July 2002
Primary Completion Date : July 2007
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood samples, DNA

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422136

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

Responsible Party: Margaretha L. Casselbrant, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00422136     History of Changes
Other Study ID Numbers: R01DC005630 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Margaretha L. Casselbrant, University of Pittsburgh:
middle ear

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases