Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00393900

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

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 :

Aug 1, 2006

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 Children with tympanostomy tubes for chronic OME

Outcome Measures

Primary Outcome Measures

middle ear status [12 months]
middle-ear status at 12 months after tympanostomy tube became non-functional

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

Principal Investigator: William J Doyle, PhD, Department of Otolaryngology, Children's Hospital of Pittsburgh
Study Director: Ellen Mandel, MD, University of Pittsburgh