Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00393900
Study type	Observational
Source	University of Pittsburgh
Contact
Status	Completed
Phase	N/A
Start date	August 2006
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03590912` - Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion	Phase 4
Completed	`NCT03611842` - Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Not yet recruiting	`NCT01421199` - Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children	N/A
Completed	`NCT01202578` - Evaluation of the Tympanostomy Tube Delivery System	Phase 2/Phase 3
Completed	`NCT00629694` - Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy	Phase 2
Completed	`NCT00520039` - Osteopathic Otitis Media Research Study	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Not yet recruiting	`NCT05402267` - The Effects of Exosomes in Otitis Media With Effusion
Not yet recruiting	`NCT04584073` - Secretory Otitis Media in Adenoids Hypertrophy Patients	N/A
Withdrawn	`NCT00736112` - Food Allergy - Tubes - Adenoids (FATA) Trial	N/A
Completed	`NCT00546117` - A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion	N/A
Withdrawn	`NCT02950311` - Xylitol for Otitis Media	Phase 2/Phase 3
Recruiting	`NCT05324696` - Autoinflation: Alternative in the Treatment of Otitis Media With Effusion	N/A
Recruiting	`NCT05353569` - Coherent Optical Detection of Middle Ear Disease	N/A
Completed	`NCT02282540` - Novel Imaging of the Eustachian Tube; Patient Study	N/A
Not yet recruiting	`NCT03491098` - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study	Early Phase 1
Completed	`NCT01082029` - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children	Phase 4
Completed	`NCT00939796` - Clinical Study of the Tympanostomy Tube Delivery System	N/A
Recruiting	`NCT06316635` - Microplastics in Otitis Media With Effusion Material
Recruiting	`NCT02215681` - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study	N/A