Eustachian Tube Function and Myringoplasty/Tympanoplasty

Stopped early

Conditions studied: Tympanic Membrane Perforation

In brief

This study will determine whether the likely success of closing a hole in the eardrum can be predicted by testing Eustachian tube function. The Eustachian tube is a natural tube that connects the back of the nose with the middle ear. When a person goes up in an airplane and their ears "pop" or when one yawns and their ears "pop", that is the Eustachian tube opening. The Eustachian tube is responsible for keeping the air pressure in the middle ear the same as in the environment and keeping the middle ear free of fluid. It is thought that in children with middle-ear disease, the muscles that open the Eustachian tube do not work very well; this seems to get better in many children as they get older. It is thought that poor Eustachian tube function is the cause of failures when holes in the eardrum are patched and also for the recurrence of fluid in the middle-ear. The primary goal of this study is to see whether it can be predicted, based on testing Eustachian tube function before surgery, whether patching the eardrum will be successful and whether fluid will come back in the ear after it is patched.

Key facts

Study ID

NCT01766856

Run by

University of Pittsburgh

People needed

19

Starts

2012-11-01

Expected to finish

2017-11-02

Last updated by the study team

2018-01-09

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3-16 years old
• being scheduled for myringoplasty/tympanoplasty with removal of a patent tube or for repair of existing eardrum perforation remaining after a tube
• less than or equal to 8 weeks prior to surgery

You may not qualify if…

• syndromic or with craniofacial malformation (eg, Down syndrome, cleft palate)
• parent anticipates being unable to keep appointments (e.g., moving out of area)
• child unable to tolerate testing

Where it is running

• ENT Research Center, Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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