Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults

Conditions
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Eustachian Tube Dysfunction

Intervention / Treatment
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* Device: EarPopper
* Device: Tympanometry
* Device: Tubomanometry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TMM followed by EarPopper + Tympanometry<br>Participants will be asked to complete the tubomanometry (TMM) then EarPopper plus tympanometry tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize Eustachian tube (ET) pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, Fish maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. | Device: EarPopper<br>* The EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, Fish, blowing out into the EMST-150).<br>Device: Tympanometry<br>* The Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change.<br>Device: Tubomanometry<br>* Tubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, Fish, blowing out into the EMST-150).<br>|
| EarPopper + Tympanometry followed by TMM<br>Participants will be asked to complete the EarPopper plus tympanometry then TMM tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize ET pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, Fish maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. | Device: EarPopper<br>* The EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, Fish, blowing out into the EMST-150).<br>Device: Tympanometry<br>* The Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change.<br>Device: Tubomanometry<br>* Tubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, Fish, blowing out into the EMST-150).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubomanometry, EarPopper, Eustachian tube function test