Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing

NCT03850197 | Completed FDA Device

• 2 other identifiers: PRO18050569P50DC007667
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Dysfunction

Keywords

Tubomanometry; EarPopper; Eustachian tube function test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Middle ear pressure change after "Fish" maneuver

  Immediately before/after "Fish" maneuver

• Middle ear pressure change after blowing into EMST-150

  Immediately before/after blowing into EMST-150

Other Outcomes (2)

• Movement of tympanic membrane during a swallow

  Immediately before/after swallow

• Soft palate elevation to 50% or more of the visual field in 0-degree nasal endoscopy during "Fish" maneuver.

  Immediately before/after "Fish" maneuver

Study Arms (2)

TMM followed by EarPopper + Tympanometry

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; Device: Tympanometry; Device: Tubomanometry

EarPopper + Tympanometry followed by TMM

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; Device: Tympanometry; Device: Tubomanometry

Interventions

EarPopper DEVICE

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).

EarPopper + Tympanometry followed by TMM; TMM followed by EarPopper + Tympanometry

Tympanometry DEVICE

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.

EarPopper + Tympanometry followed by TMM; TMM followed by EarPopper + Tympanometry

Tubomanometry DEVICE

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).

EarPopper + Tympanometry followed by TMM; TMM followed by EarPopper + Tympanometry

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cuneyt M. Alper: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• Schilder AG, Bhutta MF, Butler CC, Holy C, Levine LH, Kvaerner KJ, Norman G, Pennings RJ, Poe D, Silvola JT, Sudhoff H, Lund VJ. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. 2015 Oct;40(5):407-11. doi: 10.1111/coa.12475. No abstract available.

  PMID: 26347263 BACKGROUND

• Ars B, Dirckx JJJ. Tubomanometry. In: Ars B, ed. Fibrocartilaginous Eustachian Tube-Middle ear cleft. The Hague, The Netherlands: Kugler Publications; 2003:151-158.

  BACKGROUND

• Esteve D. Tubomanometry and Pathology. In: Ars B, ed. Fibrocartilaginous Eustachian Tube - Middle Ear Cleft. The Hauge, The Netherlands: Kugler Publications; 2003:159-175.

  BACKGROUND

• Smith ME, Zou CC, Baker C, Blythe AJC, Hutchinson PJA, Tysome JR. The repeatability of tests of eustachian tube function in healthy ears. Laryngoscope. 2017 Nov;127(11):2619-2626. doi: 10.1002/lary.26534. Epub 2017 Feb 22.

  PMID: 28224679 BACKGROUND

• Gurtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol. 2015 Mar;36(3):437-43. doi: 10.1097/MAO.0000000000000631.

  PMID: 25356762 BACKGROUND

• Schroder S, Lehmann M, Ebmeyer J, Upile T, Sudhoff H. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015 Dec;40(6):629-38. doi: 10.1111/coa.12429.

  PMID: 25867023 BACKGROUND

• Sheer FJ, Swarts JD, Ghadiali SN. Finite element analysis of eustachian tube function in cleft palate infants based on histological reconstructions. Cleft Palate Craniofac J. 2010 Nov;47(6):600-10. doi: 10.1597/09-131. Epub 2010 Mar 10.

  PMID: 20500073 BACKGROUND

• Alper CM, Teixeira MS, Swarts JD, Doyle WJ. Quantitative description of eustachian tube movements during swallowing as visualized by transnasal videoendoscopy. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):160-8. doi: 10.1001/jamaoto.2014.3002.

  PMID: 25474183 BACKGROUND

MeSH Terms

Interventions

Acoustic Impedance Tests

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Cuneyt M Alper, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 21, 2019
• Study Start: February 27, 2019
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)