Status:
COMPLETED
Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
Lead Sponsor:
Cuneyt M. Alper
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Pittsburgh
Conditions:
Eustachian Tube Dysfunction
Eligibility:
All Genders
5-60 years
Brief Summary
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 heal...
Detailed Description
There is no current universally-accepted set of functional tests or scoring systems for the diagnosis of ETD or measure of the pressure-regulating function of the ET; current practice shows that the d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03850197
Start Date
February 27 2019
End Date
November 18 2019
Last Update
November 13 2020
Active Locations (1)
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1
ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118
Pittsburgh, Pennsylvania, United States, 15213