Eustachian Tube Dysfunction Clinical Trial
Official title:
Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
Verified date | November 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 18, 2019 |
Est. primary completion date | November 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 60 Years |
Eligibility | INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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. |
Country | Name | City | State |
---|---|---|---|
United States | ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118 | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Cuneyt M. Alper | National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh |
United States,
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Ars B, Dirckx JJJ. Tubomanometry. In: Ars B, ed. Fibrocartilaginous Eustachian Tube-Middle ear cleft. The Hague, The Netherlands: Kugler Publications; 2003:151-158.
Esteve D. Tubomanometry and Pathology. In: Ars B, ed. Fibrocartilaginous Eustachian Tube - Middle Ear Cleft. The Hauge, The Netherlands: Kugler Publications; 2003:159-175.
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Sheer FJ, Swarts JD, Ghadiali SN. Finite element analysis of eustachian tube function in cleft palate infants based on histological reconstructions. Cleft Palate Craniofac J. 2010 Nov;47(6):600-10. doi: 10.1597/09-131. Epub 2010 Mar 10. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Movement of tympanic membrane during a swallow | Video otoscopy will be done while subject undergoes the EarPopper plus tympanometry test; movement of the tympanic membrane during a swallow will indicate Eustachian tube opening. | Immediately before/after swallow | |
Other | Soft palate elevation to 50% or more of the visual field in 0-degree nasal endoscopy during "Fish" maneuver. | Rigid nasal endoscopy with 0-degree scope will be done on adult subjects while they perform the "Fish" maneuver. Soft palate elevation to 50% or more of the visual field is postulated to be a function of efficient eustachian tube function. | Immediately before/after "Fish" maneuver | |
Primary | Middle ear pressure change after a swallow | The subject's middle ear pressure will be measured before and after they are asked to swallow, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening. | Immediately before/after swallow | |
Secondary | Middle ear pressure change after "Fish" maneuver | The subject's middle ear pressure will be measured before and after they are asked to carry out the "Fish" maneuver, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening. The "Fish" maneuver is an effort-dependent method of elevating the soft palate, and will provide further qualitative data on Eustachian tube function. | Immediately before/after "Fish" maneuver | |
Secondary | Middle ear pressure change after blowing into EMST-150 | The subject's middle ear pressure will be measured before and after they are asked to blow out against different levels of resistance into the EMST-150, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening. Blowing into the EMST-150 is a standardized method of elevating the soft palate, and will provide further qualitative data on Eustachian tube function. | Immediately before/after blowing into EMST-150 |
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