Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William J Doyle, PhD, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00393900
First received: October 30, 2006
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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
Otitis Media With Effusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Resource links provided by NLM:


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

Primary Outcome Measures:
  • middle ear status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    middle-ear status at 12 months after tympanostomy tube became non-functional


Biospecimen Retention:   Samples With DNA

Buccal cells obtained for DNA


Enrollment: 84
Study Start Date: August 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children with tympanostomy tubes for chronic OME

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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
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

Criteria

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
  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 ClinicalTrials.gov identifier: NCT00393900

Locations
United States, Pennsylvania
ENT Department, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: William J Doyle, PhD Department of Otolaryngology, Children's Hospital of Pittsburgh
Study Director: Ellen Mandel, MD Children's Hospital of Pittsburgh
  More Information

Publications:
Responsible Party: William J Doyle, PhD, Professor of Otolaryngology, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00393900     History of Changes
Other Study ID Numbers: #0605013, NIH 1P50DC007667
Study First Received: October 30, 2006
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
otitis media
tympanostomy tube
eustachian tube function
gas exchange
tympanostomy tubes

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

ClinicalTrials.gov processed this record on September 30, 2014