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Eustachian Tube Dysfunction

Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing

Sponsored by Cuneyt M. Alper

About this trial

Last updated 5 years ago

Study ID

PRO18050569

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
5 to 60 Years
All
All

Trial Timing

Ended 6 years ago

What is this trial about?

The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when flying in an airplane or going up a tall building in an elevator. Many people with ETD also suffer from ear problems such as repeated middle-ear infections or fluid in the ears. However, there are very few easily-administered tests to measure and assess Eustachian tube function (ETF). Tubomanometry is one of these tests, however it is expensive and used to measure ETF only in research settings. In this study, the investigators propose that using a combination of two readily available devices, the EarPopper and a tympanometer, will work in a manner similar to a Tubomanometer to test ET function.

What are the participation requirements?

Yes

Inclusion Criteria

- Bilaterally intact tympanic membranes

- aged 5 to 60; generally good health

- ability to understand and give informed consent

- history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear fluids, or prior ETD diagnosis

- ability to perform maneuvers that will be done during the testing protocol. Control participants

- Bilaterally intact tympanic membranes

- aged 5 to 60

- generally good health

- ability to understand and give informed consent

- no personal history of recurrent otitis media or other middle--ear disease

- ability to perform maneuvers that will be done during the testing protocol

- no difficulty equalizing middle--ear pressures in daily life.

No

Exclusion Criteria

- Cold/allergic rhinitis (temporary) on presentation

- current dental problem or dental work within 7 days (temporary)

- history of ossicular reconstruction

- history of tympanoplasty

- syndromes predisposing to otitis media

- extant middle--ear disease

- inability to complete testing protocols

- tympanic membrane perforation

- abnormal tympanogram (type B tympanogram)

- BMI >40

- history of congenital heart disease

- prior radiation to head and neck

- uncontrolled respiratory disease

- any medical condition or use of medication for which the study physician feels study procedures would not be in the subject's best interest.

- In adults, a positive urine pregnancy test (in females), blood pressure above 140/90, glaucoma, and sensitivity to drugs used to prepare the nose for endoscopic examination will also exclude potential participants. Control participants:

- (in addition to above) significant middle--ear disease history

- evidence of middle ear pathology.