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.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT Department, Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

middle ear status

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Oct 31, 2006
Registry last updated: Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed