Eustachian Tube DysfunctionNCT01661777
Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops
A study testing Nasal steroid, Myringotomy tube placement and Diuretic in people with Eustachian Tube Dysfunction and Endolymphatic Hydrops, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eustachian Tube Dysfunction, Endolymphatic Hydrops
- What is being tested?
- Nasal steroid, Myringotomy tube placement and Diuretic
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center--Division of Neurotology
Nashville, Tennessee, 37212
About this study
Official title: Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?
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.
Read the 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.
- Conditions
- Eustachian Tube Dysfunction, Endolymphatic Hydrops
- Being tested
- Nasal steroid, Myringotomy tube placement, Diuretic, Antihistamine, Low salt diet
- Keywords
- Eustachian tube dysfunction, Endolymphatic hydrops, Diuretic, Low salt diet, Myringotomy, Pressure equalization tube, Ear tube, Ear fullness, Ear pressure, Allergy, Nasal steroid, Antihistamine
- Medical subject headings
- Endolymphatic Hydrops, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal steroidDrug
Myringotomy tube placementProcedure or surgery
DiureticDrug
AntihistamineDrug
Low salt dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nasal steroid and Antihistamine | Other | Patients with ETD will be given nasal steroid and antihistamine for 8 weeks. Receives: Drug: Nasal steroid; Drug: Antihistamine |
| Myringotomy tubes | Active comparator | Patients who fail nasal steroid and antihistamine treatment will have myringotomy tubes placed. Receives: 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 Receives: Drug: Diuretic; Behavioral: Low salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georges Wanna, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661777
- Sponsor's protocol ID
- JR08012012112856
- Status last verified
- May 2014
- First submitted
- 7 Aug 2012
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops?
- ClinicalTrials.gov ID
- NCT01661777
- Acronym / sponsor ID
- JR08012012112856
- Conditions
- Eustachian Tube Dysfunction, Endolymphatic Hydrops
- Keywords
- Eustachian tube dysfunction, Endolymphatic hydrops, Diuretic, Low salt diet, Myringotomy, Pressure equalization tube, Ear tube, Ear fullness
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasal steroid and Antihistamine | Other | Drug: Nasal steroid, Drug: AntihistaminePatients with ETD will be given nasal steroid and antihistamine for 8 weeks. |
| Myringotomy tubes | Active comparator | Procedure: Myringotomy tube placementPatients who fail nasal steroid and antihistamine treatment will have myringotomy tubes placed. |
| Low salt diet and diuretic | Active comparator | Drug: Diuretic, Behavioral: Low salt dietPatient's who fail to improve with myringotomy tubes will be treated with low salt det and diuretic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal steroid | Drug | Nasal steroid and Antihistamine |
| Myringotomy tube placement | Procedure or surgery | Myringotomy tubes |
| Diuretic | Drug | Low salt diet and diuretic |
| Antihistamine | Drug | Nasal steroid and Antihistamine |
| Low salt diet | Behavioural | Low salt diet and diuretic |
Primary outcome
Improvement in patient ETD symptoms with nasal steroid and antihistamine alone
Time frame: 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
Time frame: 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
Time frame: 2 years
Determine the degree of improvement of patient symptoms in the setting of refractory ETD after a low salt diet and diuretic treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal steroid, Myringotomy tube placement and Diuretic in people with Eustachian Tube Dysfunction and Endolymphatic Hydrops, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patient ETD symptoms with nasal steroid and antihistamine alone (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.