Tympanostomy Tubes Versus Eustachian Tube Dilation

February 6, 2023 updated by: Hae-Ok Kim, Columbia University

The objective of this study is to determine whether tympanostomy with pressure equalization tube placement or Eustachian tube (ET) dilation is superior at reducing symptoms of patients with ET dysfunction.

Given the apparent promise of Eustachian tube dilation and the lack of head to head comparison to the more traditional tympanostomy tube, this study seeks to compare them in a head to head manner in order to assess superiority in regards to ETDQ-7 and tympanogram improvements.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The eustachian tube serves to ventilate and equalize middle ear pressure; clear secretions from the middle ear with mucociliary action; and protect the middle ear from sounds, pathogens, and secretions from the nasopharynx. First described anatomically by Eustachius in 1563 and with its exact function worked out a century later, Valsalva realized in 1703 that its opening was dynamic, not static, and described the namesake maneuver to expel pus from the middle ear into the external auditory canal. By the mid 18th century, multiple authors had attempted Eustachian tube catheterization and by the early 19th century, catheterization with irrigation and air insufflation had been described.(1) This shows how Eustachian tube dilation has been a known treatment for centuries, despite its relative obscurity prior to this decade. ET dysfunction is a common diagnosis many patients receiving care from an otologist or otolaryngologist receive. Dysfunction can be broken down into dilatory, which is caused by inflammation such as a virus, baro-challenge induced such as in scuba divers or those taking flights and patulous, which is of unclear etiology.(2) Symptoms are thought to include but are not limited to ear fullness, the sensation that the ear is underwater, otalgia, muffled hearing, tinnitus, autophony and ear popping amongst others. Clear diagnostic criteria are not present, though it is generally felt that a combination of symptoms and objective findings on otoscopy or tympanogram are enough to support the diagnosis. Many have resorted to using the Eustachian Tube Dysfunction Questionnaire-7 which is a validated symptom driven assessment, although it is only moderately associated with objective measures of ET dysfunction. (3,4) The only population-based study looking at prevalence used otoscopy, tympanogram and audiometry to estimate that it affects 0.9% of adults.(5) Unfortunately, there is currently no gold standard for treatment of ET dysfunction.

The only randomized control study of medical treatments showed no impact of nasal steroids on ET dysfunction.(6) The most common surgical option is a tympanostomy tube, which has been used since the 1950s for both middle ear effusions and ET dysfunction.(7) Tympanostomy tubes can alleviate tympanic membrane retraction, atelectasis and effusion, although they do not address the underlying etiology of the ET dysfunction. Numerous nonrandomized and or noncontrolled studies have showed improvement in symptoms with tympanostomy tube placement. Depending on the study and the definition, 70-100% improvement has been reported. Despite this, high-level evidence for tympanostomy tube efficacy in ET dysfunction remains lacking.(8) Adenoidectomy has also been proposed as a way to improve ET function, but not surprisingly, most studies have shown that it only helps if the adenoids are found to be abutting or obstructing the torus tubarii.(9,10) Furthermore, these studies focus on children, and the adenoid pad is not likely to be a contributing factor in most adults. Eustachian tube balloon dilation recently came back into the mainstream beginning with the 2010 study by Ockermann et al. which showed the procedure was safe and produced good results in a small cohort. Numerous studies since then have shown efficacy, including two separate multicenter randomized controlled trials published in 2017 and 2018. Both of these showed statistically and clinically significant superiority of ET balloon dilation over control as measured by improvement in ETDQ-7 and tympanogram type at up to 1 year. (11,12,13)

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/ New York Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Determined to have chronic Eustachian tube dysfunction of at least 3 month duration based on a score of ≥ 14.5 on the Eustachian tube dysfunction questionnaire-7 (ETDQ-7), regardless of tympanogram status

Exclusion Criteria:

  • Insurance that does reimburse for ET balloon dilation
  • Patients with acute upper respiratory infection
  • Tympanic membrane perforation
  • Known middle ear disease such as cholesteatoma, acute otitits media, history of head and neck radiation, history of cleft palate, cystic fibrosis, ciliary dyskinesia, nasopharyngeal mass and patulous eustachian tube

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tympanostomy with tubes
Tympanostomy with pressure equalization tube placement with Ventilation (Tympanostomy) Tubes
Procedure: Reducing symptoms of Eustachian tube dysfunction
One of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared
EXPERIMENTAL: Eustachian tube (ET) dilation
Eustachian tube (ET) dilation with ACCLARENT AERA® Eustachian Tube Balloon Dilation System
Procedure: Reducing symptoms of Eustachian tube dysfunction
One of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETDQ-7 score
Time Frame: Baseline
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
Baseline
ETDQ-7 score
Time Frame: 6-weeks
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
6-weeks
ETDQ-7 score
Time Frame: 3-months
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
3-months
ETDQ-7 score
Time Frame: 6-months
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
6-months
ETDQ-7 score
Time Frame: 1-year
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
1-year
Tympanogram
Time Frame: Baseline
The patient's post-op tympanogram will be recorded to compare to follow-up visits.
Baseline
Tympanogram
Time Frame: 6-weeks
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
6-weeks
Tympanogram
Time Frame: 3-months
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
3-months
Tympanogram
Time Frame: 6-months
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
6-months
Tympanogram
Time Frame: 1 year
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Ana Kim, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (ACTUAL)

March 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS2555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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