Clinical trial NCT03850197: Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
Official title: Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eustachian Tube Dysfunction
Keywords: Tubomanometry
EarPopper
Eustachian tube function test
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Pittsburgh
First posted: 2019-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 10 healthy adults (aged 18-60), 5 healthy children (aged 5-17), 10 otherwise healthy adults with ETD (aged 18-60), and 5 otherwise healthy children with ETD (aged 5-17) with bilaterally intact TM's will be enrolled after obtaining informed consent. Complete histories will be taken with a focus on any ear-related problems.

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 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.

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 diagnosis of ETD relies largely on clinical observation. Though there are several tests that have been developed to characterize ETF, many of them require specialized equipment and trained personnel to administer the test, which are only available in specialized testing centers. As such, this study aims to compare the use of the EarPopper plus tympanometry to Tubomanometry as a ETF test.

Tubomanometry is a simple in-office test based on the Politzer maneuver, in which air is blown into one of the nostrils while occluding the contralateral nostril and swallowing. The tubomanometer consists of an air pump attached to a manometer to adjust the target pressure, a two-pronged nose piece to deliver a controlled airflow to the nostrils and an external ear canal sensor to detect displacement of the tympanic membrane (TM). Since the middle ear is a closed system, displacement of the TM during a swallow is considered a successful ET opening. Tubomanometry is easily tolerated by both adults and children is currently used most widely to evaluate ETF changes after ET balloon dilation. The EarPopper is, like the tubomanometer, a modified politzer device and is used as a treatment device for ET obstruction. It introduces a continuous airflow into the nostril and has no external ear canal probe. The user perceives the ET opening as a subjective sensation of ear fulness. In this pilot study, the investigators will test the feasibility of a new ETF test protocol that will use the EarPopper to trigger the opening of the ET followed by a tympanogram to confirm if there was a change in middle ear pressure. The investigators expect that the combination of these two devices will be comparable to the Tubomanometry test, which will also be performed in the same test session.

Previous studies show that ET opening efficiency is determined by the coordinated function of paratubal muscles, especially of the levator (mLVP) and tensor veli palatini (mTVP) muscles. Nasal endoscopy video recordings have shown a large variability in soft palate closure, as it depends largely on individual effort. For this reason, besides swallowing, the investigators will also employ two additional methods to standardize the elevation of the soft palate and facilitate the opening of the ET: the Fish maneuver (puffing the cheeks and blowing out against a closed mouth) and the EMST-150 device (blowing into the device with a preset low and high resistances). As part of the development of this new testing protocol, these three maneuvers will be used during the EarPopper plus tympanometry and Tubomanometry tests. They will be performed during the EarPopper test, with concurrent video-otoscopy recordings to detect movement of the tympanic membrane that could be interpreted as an ET opening, and during trans-nasal video-endoscopy to record the movement and positioning of the soft palate.

The investigators expect that, in comparing the maneuvers performed during EarPopper plus tympanometry and Tubomanometry tests, they will assess the feasibility of the protocol, define maneuvers to standardize paratubal muscular contraction and determine if the EarPopper plus tympanometry measurements are comparable to Tubomanometry.

Eligibility criteria: 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.

Primary outcomes:
measure: Middle ear pressure change after a swallow
timeFrame: Immediately before/after swallow
Secondary outcomes:
measure: Middle ear pressure change after "Fish" maneuver
timeFrame: Immediately before/after "Fish" maneuver
measure: Middle ear pressure change after blowing into EMST-150
timeFrame: Immediately before/after blowing into EMST-150
Other outcomes:
measure: Movement of tympanic membrane during a swallow
timeFrame: Immediately before/after swallow
measure: Soft palate elevation to 50% or more of the visual field in 0-degree nasal endoscopy during "Fish" maneuver.
timeFrame: Immediately before/after "Fish" maneuver
Locations:
city: Pittsburgh
country: United States
facility: ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Cuneyt M Alper, MD
role: PRINCIPAL_INVESTIGATOR
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