Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
Condition: Eustachian Tube Dysfunction
Study type: Observational

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.
    

Intervention name(s): EarPopper; Tympanometry; Tubomanometry
Intervention type(s): Device; Device; Device
Intervention description(s): 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).; 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.; 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).
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.
      
Keywords: Tubomanometry; EarPopper; Eustachian tube function test