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

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

The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian tube dysfunction with standard treatment for endolymphatic hydrops. Eustachian tube dysfunction is a common diagnosis made in otolaryngology related to abnormal pressure equalization of the middle ear space related to a swollen, inflamed, or occluded Eustachian tube. The symptoms of this include perceived hearing loss, a feeling of fullness in the affected ear/ears, ear pain, ear popping, and occasionally imbalance. These symptoms overlap with a more rare and difficult to diagnose condition known as endolymphatic hydrops, or an overproduction to fluid in the inner ear. The treatment for these two conditions are distinct and traditionally, patients are treated for Eustachian tube dysfunction first as it is much more common and there are several treatments, namely nasal steroids, antihistamines, and pressure equalization tubes. For patients who do not improve with these treatments, they are often treated with diuretics and a low salt diet to treat for supposed endolymphatic hydrops. There has never been a study to investigate the utility of these treatments in patients with refractory Eustachian tube dysfunction. There is also reason to believe that chronic ETD with effusion can lead to both inner and middle ear dysfunction. Thus, this study aims to determine the benefit of standard endolymphatic hydrops treatment on patient with refractory Eustachian tube dysfunction symptoms in a prospective fashion.

Hypothesis:

Patients with refractory Eustachian tube dysfunction (patients with no or minimal symptom improvement despite nasal steroid and antihistamine treatment followed by myringotomy tube placement) have an element of endolymphatic hydrops and these patient's symptoms will improve with a low sodium diet and diuretic.

Study Overview

• Status: Withdrawn
• Conditions: Endolymphatic Hydrops; Eustachian Tube Dysfunction
• Intervention / Treatment: Drug: Antihistamine; Behavioral: Low salt diet; Drug: Nasal steroid; Procedure: Myringotomy tube placement; Drug: Diuretic

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center--Division of Neurotology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Non-smoker
• Normotensive or hypertensive (systolic blood pressure >115, diastolic blood pressure >75)
• Normal renal function (Cr <1.00)
• Not currently on acetazolamide
• Not currently on a low salt diet
• Competent in decision making process and able to sign a written informed consent form.
• No other previous alternative otologic diagnosis

Exclusion Criteria:

• Smoking
• Kidney disease (Cr >1.00)
• Hypotension (systolic blood pressure <115, diastolic blood pressure <75)
• Strong history of vascular disease (heart attack, stroke, heart failure, peripheral vascular disease i.e. claudication, gangrene, amputation)
• Alternative otologic diagnosis (Meniere's disease)
• Allergy or adverse reaction to previous administration of hydrochlorothiazide/triamterene
• Concurrent aspirin use
• Current or planned pregnancy during the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nasal steroid and Antihistamine; Patients with ETD will be given nasal steroid and antihistamine for 8 weeks.	Drug: Antihistamine; Drug: Nasal steroid
Active Comparator: Myringotomy tubes; Patients who fail nasal steroid and antihistamine treatment will have myringotomy tubes placed.	Procedure: Myringotomy tube placement
Active Comparator: Low salt diet and diuretic; Patient's who fail to improve with myringotomy tubes will be treated with low salt det and diuretic	Behavioral: Low salt diet; Drug: Diuretic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient ETD symptoms with nasal steroid and antihistamine alone	Determine the degree to which ETD symptoms are relieved with nasal steroid and antihistamine alone.	2 years
Improvement in patient ETD symptoms with pressure equalization tubes	Determine the degree to which patient's symptoms related to ETD improve after placement of pressure equalization tubes.	2 years
Improvement in patients with refractory ETD symptoms with treatment for endolymphatic hydrops with a diuretic and low salt diet	Determine the degree of improvement of patient symptoms in the setting of refractory ETD after a low salt diet and diuretic treatment.	2 years

Collaborators and Investigators

• Sponsor: Vanderbilt University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Allergy; Diuretic; Eustachian tube dysfunction; Antihistamine; Endolymphatic hydrops; Low salt diet; Myringotomy; Pressure equalization tube; Ear tube; Ear fullness; Ear pressure; Nasal steroid
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Edema; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Histamine Agents; Diuretics; Histamine H1 Antagonists; Histamine Antagonists
• Other Study ID Numbers: JR08012012112856