Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
Completed
Conditions studied: Eustachian Tube Dysfunction
In brief
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.
Key facts
- Study ID
- NCT03850197
- Run by
- Cuneyt M. Alper
- People needed
- 30
- Starts
- 2019-02-27
- Expected to finish
- 2019-11-18
- Last updated by the study team
- 2020-11-13
Who can join
Age: 5 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ETD participants:
- 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.
You may not qualify if…
- ETD participants:
- 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.
Where it is running
- ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118 — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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