Eustachian Tube Dysfunction Clinical Trial
Official title:
Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?
Verified date | May 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center--Division of Neurotology | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
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