Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Otitis Media With Effusion Clinical Trial

Official title:

Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393900
• Other study ID #: #0605013
• Secondary ID: NIH 1P50DC007667
• Status: Completed
• Phase: N/A
• First received: October 30, 2006
• Last updated: October 17, 2017
• Start date: August 2006
• Est. completion date: October 2012

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Locations

Country	Name	City	State
United States	ENT Department, Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	middle ear status	middle-ear status at 12 months after tympanostomy tube became non-functional	12 months