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临床试验/NCT01661777
NCT01661777撤回不适用

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

Vanderbilt University1 个研究点 分布在 1 个国家开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Improvement in patient ETD symptoms with nasal steroid and antihistamine alone

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any male or female patient 18-70 years old diagnosed with Eustachian tube dysfunction, as determined by clinical evaluation of symptoms and positive ETDQ-
  • 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

排除标准

  • 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

研究组 & 干预措施

Nasal steroid and Antihistamine

Other

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

干预措施: Nasal steroid (Drug)

Nasal steroid and Antihistamine

Other

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

干预措施: Antihistamine (Drug)

Myringotomy tubes

Active Comparator

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

干预措施: Myringotomy tube placement (Procedure)

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

干预措施: Diuretic (Drug)

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

干预措施: Low salt diet (Behavioral)

结局指标

主要结局

Improvement in patient ETD symptoms with nasal steroid and antihistamine alone

时间窗: 2 years

Determine the degree to which ETD symptoms are relieved with nasal steroid and antihistamine alone.

Improvement in patient ETD symptoms with pressure equalization tubes

时间窗: 2 years

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

时间窗: 2 years

Determine the degree of improvement of patient symptoms in the setting of refractory ETD after a low salt diet and diuretic treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georges Wanna

assistant professor

Vanderbilt University

研究点 (1)

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