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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.
ClinicalTrials.gov Identifier: NCT00393900
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

October 30, 2006
October 31, 2006
October 19, 2017
August 2006
October 2012   (Final data collection date for primary outcome measure)
middle ear status [ Time Frame: 12 months ]
middle-ear status at 12 months after tympanostomy tube became non-functional
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Complete list of historical versions of study NCT00393900 on ClinicalTrials.gov Archive Site
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Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
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.
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.
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Buccal cells obtained for DNA
Probability Sample
Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment
Otitis Media With Effusion
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Children with tympanostomy tubes for chronic OME
Mandel EM, Swarts JD, Casselbrant ML, Tekely KK, Richert BC, Seroky JT, Doyle WJ. Eustachian tube function as a predictor of the recurrence of middle ear effusion in children. Laryngoscope. 2013 Sep;123(9):2285-90. doi: 10.1002/lary.24021. Epub 2013 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
NIH 1P50DC007667
Not Provided
Plan to Share IPD: No
Ellen M. Mandel, University of Pittsburgh
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
University of Pittsburgh
October 2017