Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
Data Collection
Collected at a single point in time - Cross-sectionalCase-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: February 27, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118
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