Suspended

Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?

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What is being tested

Nasal steroid

+ Antihistamine

+ Myringotomy tube placement

DrugProcedureBehavioral
Who is being recruted

Ear Diseases+3

+ Immune System Diseases

+ Labyrinth Diseases

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Eustachian tube dysfunction is one of the most common problems encountered in general otolaryngology clinical practice. Symptoms of ear pressure, decreased hearing, ear pain, ear popping, and frequent ear infections are often blamed on the inability of the Eustachian tube to equalize air pressure across the ear drum. If the Eustachian tube is occluded, the middle ear space becomes a closed chamber in which normal gas exchange cannot occur. Treatment of Eustachian dysfunction has traditionally focused on a two tier system. First, patients are most often placed on a nasal steroid and an antihistamine. This medication regimen leads to decreased nasal inflammation, mucosal swelling, and treats nasal allergy. In many patients, this treatment improves symptoms completely or reduces them to a tolerable level. If the patient's symptoms are not improved, the next step in management is to create a surgical tract to the middle ear via a myringotomy (a hole across the ear drum) and placing a pressure equalization tube across the tympanic membrane. This bypasses any anatomical obstruction in the Eustachian tube and allows the middle ear pressure to equalize with the atmospheric pressure across the tympanic membrane. Unfortunately, despite this, there are patients with refractory symptoms, often ear pressure and subjectively decreased hearing. These symptoms are also frequently associated with inner ear disease, specifically endolymphatic hydrops. Endolymphatic hydrops is felt to be related to over production of endolymphatic fluid, the fluid within the inner ear. Thus, we propose that patient's will refractory Eustachian tube dysfunction are experiencing an inner ear phenomenon, and that they would benefit from treatment similar to how endolymphatic hydrops (or over production of endolymphatic fluid) is managed. The mainstays of management of endolymphatic hydrops are a low sodium diet and diuretic treatment (hydrochlorothiazide/triamterene). Both of these treatments aim to reduce endolymph production.

Principal SponsorVanderbilt University
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesImmune System DiseasesLabyrinth DiseasesOtorhinolaryngologic DiseasesHypersensitivityEndolymphatic Hydrops

Criteria

8 inclusion criteria required to participate
Any male or female patient 18-70 years old diagnosed with Eustachian tube dysfunction, as determined by clinical evaluation of symptoms and positive ETDQ-7

Competent in decision making process and able to sign a written informed consent form

No other previous alternative otologic diagnosis

Non-smoker

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8 exclusion criteria prevent from participating
Allergy or adverse reaction to previous administration of hydrochlorothiazide/triamterene

Alternative otologic diagnosis (Meniere's disease)

Concurrent aspirin use

Current or planned pregnancy during the course of the study

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Patients with ETD will be given nasal steroid and antihistamine for 8 weeks.

Group II

Active Comparator
Patients who fail nasal steroid and antihistamine treatment will have myringotomy tubes placed.

Group III

Active Comparator
Patient's who fail to improve with myringotomy tubes will be treated with low salt det and diuretic

Study Objectives

Primary 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

Vanderbilt University Medical Center--Division of Neurotology

Nashville, United StatesOpen Vanderbilt University Medical Center--Division of Neurotology in Google Maps
SuspendedOne Study Center