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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Georges Wanna, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01661777
First received: August 7, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Eustachian Tube Dysfunction
Endolymphatic Hydrops
Drug: Nasal steroid
Procedure: Myringotomy tube placement
Drug: Diuretic
Drug: Antihistamine
Behavioral: Low salt diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Improvement in patient ETD symptoms with nasal steroid and antihistamine alone [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the degree to which ETD symptoms are relieved with nasal steroid and antihistamine alone.

  • Improvement in patient ETD symptoms with pressure equalization tubes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the degree to which patient's symptoms related to ETD improve after placement of pressure equalization tubes.

  • Improvement in patients with refractory ETD symptoms with treatment for endolymphatic hydrops with a diuretic and low salt diet [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the degree of improvement of patient symptoms in the setting of refractory ETD after a low salt diet and diuretic treatment.


Enrollment: 0
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nasal steroid and Antihistamine
Patients with ETD will be given nasal steroid and antihistamine for 8 weeks.
Drug: Nasal steroid Drug: Antihistamine
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
Drug: Diuretic Behavioral: Low salt diet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661777

Locations
United States, Tennessee
Vanderbilt University Medical Center--Division of Neurotology
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Georges Wanna, assistant professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01661777     History of Changes
Other Study ID Numbers: JR08012012112856
Study First Received: August 7, 2012
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Eustachian tube dysfunction
Endolymphatic hydrops
Diuretic
Low salt diet
Myringotomy
Pressure equalization tube
Ear tube
Ear fullness
Ear pressure
Allergy
Nasal steroid
Antihistamine

Additional relevant MeSH terms:
Edema
Endolymphatic Hydrops
Ear Diseases
Labyrinth Diseases
Otorhinolaryngologic Diseases
Signs and Symptoms
Diuretics
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014