Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393900
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : October 19, 2017
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Ellen M. Mandel, University of Pittsburgh

Brief Summary:
This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.

Condition or disease
Otitis Media With Effusion

Detailed Description:
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Study Start Date : August 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Children with tympanostomy tubes for chronic OME

Primary Outcome Measures :
  1. middle ear status [ Time Frame: 12 months ]
    middle-ear status at 12 months after tympanostomy tube became non-functional

Biospecimen Retention:   Samples With DNA
Buccal cells obtained for DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment

Inclusion Criteria:

  • 3-6 years old
  • History of chronic otitis media with effusion(OME)
  • Scheduled or within 6 weeks of tube insertion
  • OME at entry or surgery
  • Generally good health

Exclusion Criteria:

  • Cleft palate or other syndromes predisposing to OM
  • History of recurrent acute otitis media only
  • History of complications of OM or its treatment
  • Unable to cooperate for testing

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 identifier (NCT number): NCT00393900

United States, Pennsylvania
ENT Department, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: William J Doyle, PhD Department of Otolaryngology, Children's Hospital of Pittsburgh
Study Director: Ellen Mandel, MD University of Pittsburgh

Publications of Results:
Responsible Party: Ellen M. Mandel, Associate Professor, University of Pittsburgh Identifier: NCT00393900     History of Changes
Other Study ID Numbers: #0605013
NIH 1P50DC007667
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ellen M. Mandel, University of Pittsburgh:
otitis media
tympanostomy tube
eustachian tube function
gas exchange
tympanostomy tubes

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases