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

NCT01661777 | Withdrawn

• 1 other identifier: JR08012012112856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Nasal steroid and Antihistamine

OTHER

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

Drug: Nasal steroid; Drug: Antihistamine

Myringotomy tubes

ACTIVE COMPARATOR

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

Procedure: Myringotomy tube placement

Low salt diet and diuretic

ACTIVE COMPARATOR

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

Drug: Diuretic; Behavioral: Low salt diet

Interventions

Nasal steroid DRUG

Nasal steroid and Antihistamine

Myringotomy tube placement PROCEDURE

Myringotomy tubes

Diuretic DRUG

Low salt diet and diuretic

Antihistamine DRUG

Nasal steroid and Antihistamine

Low salt diet BEHAVIORAL

Low salt diet and diuretic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center--Division of Neurotology

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Endolymphatic Hydrops; Hypersensitivity

Interventions

Diuretics; Histamine Antagonists; Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (1)