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

Primary Purpose

Eustachian Tube Dysfunction, Endolymphatic Hydrops

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal steroid
Myringotomy tube placement
Diuretic
Antihistamine
Low salt diet
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eustachian Tube Dysfunction focused on measuring Eustachian tube dysfunction, Endolymphatic hydrops, Diuretic, Low salt diet, Myringotomy, Pressure equalization tube, Ear tube, Ear fullness, Ear pressure, Allergy, Nasal steroid, Antihistamine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center--Division of Neurotology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Nasal steroid and Antihistamine

Myringotomy tubes

Low salt diet and diuretic

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2012
Last Updated
May 28, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01661777
Brief Title
Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops
Official Title
Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Endolymphatic Hydrops
Keywords
Eustachian tube dysfunction, Endolymphatic hydrops, Diuretic, Low salt diet, Myringotomy, Pressure equalization tube, Ear tube, Ear fullness, Ear pressure, Allergy, Nasal steroid, Antihistamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal steroid and Antihistamine
Arm Type
Other
Arm Description
Patients with ETD will be given nasal steroid and antihistamine for 8 weeks.
Arm Title
Myringotomy tubes
Arm Type
Active Comparator
Arm Description
Patients who fail nasal steroid and antihistamine treatment will have myringotomy tubes placed.
Arm Title
Low salt diet and diuretic
Arm Type
Active Comparator
Arm Description
Patient's who fail to improve with myringotomy tubes will be treated with low salt det and diuretic
Intervention Type
Drug
Intervention Name(s)
Nasal steroid
Intervention Type
Procedure
Intervention Name(s)
Myringotomy tube placement
Intervention Type
Drug
Intervention Name(s)
Diuretic
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Intervention Type
Behavioral
Intervention Name(s)
Low salt diet
Primary Outcome Measure Information:
Title
Improvement in patient ETD symptoms with nasal steroid and antihistamine alone
Description
Determine the degree to which ETD symptoms are relieved with nasal steroid and antihistamine alone.
Time Frame
2 years
Title
Improvement in patient ETD symptoms with pressure equalization tubes
Description
Determine the degree to which patient's symptoms related to ETD improve after placement of pressure equalization tubes.
Time Frame
2 years
Title
Improvement in patients with refractory ETD symptoms with treatment for endolymphatic hydrops with a diuretic and low salt diet
Description
Determine the degree of improvement of patient symptoms in the setting of refractory ETD after a low salt diet and diuretic treatment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vanderbilt University Medical Center--Division of Neurotology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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

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