Patulous Eustachian Tube Dysfunction Clinical Trial
Official title:
A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube
The Eustachian tube is a tube that connects the back of the nose with the ear. Its job is to
keep the pressure on the inside of the eardrum close to the pressure outside the eardrum, so
that the eardrum can vibrate properly. Usually this tube is closed, but it opens briefly
during swallowing. In the condition called patulous eustachian tube, this tube is open all
the time. This is a benign condition but it can be very bothersome to patients.
The incidence of patulous Eustachian tube dysfunction is about 0.3-6.6% of the population.
However, about 15% of the people who have this condition are bothered enough by it that they
seek medical attention. This condition is more common in females than males and is more
common in adults than children.
Some of the common symptoms of patulous eustachian tube can include roaring tinnitus
synchronous with nasal respiration, audible respiratory sounds, sensation of a plugged ear
and fluctuating aural fullness.
In most cases the cause is idiopathic. Some predisposing factors include weight loss,
stress,anxiety,fatigue, pregnancy, and temporomandibular joint syndrome. It can also be
caused by adhesions in the nasopharynx following surgery on the adenoids. Sometimes it can
be associated with medications such as diuretics and oral contraceptives. Neuromuscular
disorders that cause atrophy such as multiple sclerosis, stroke and motor neuron disease
have also been postulated to cause patulous eustachian tube.
The purpose of this trial is to learn more about the condition and help us learn about how
the eardrum might be treated to prevent it vibrating with sounds or noises coming up the
Eustachian tube.
The first part of the study will consist of a questionnaire to help to further define the
symptoms of patulous eustachian tube, and to measure how severe these symptoms are.
Currently there are few treatments that are satisfactory for patients. Common surgical
therapies include injections of various substances into the Eustachian tube opening
including paraffin, Teflon,or gelfoam. Unfortunately, these methods are either temporary or
have lead to serious complications including cerebral thrombosis and death (due to
inadvertent injection into the carotid artery). Other treatments have focused on cauterizing
the Eustachian tube opening but these have been either unsatisfactory or caused damage to
the trigeminal nerve. Myringotomy and insertion of a ventilation tube has helped some
patients but others have found that this increased the patient's discomfort.
The investigators have been treating patients recently by placing some putty like clay
material on the eardrum, which stops it vibrating so much with the patient's own voice, and
this appears to be quite effective for many patients. It is also easily removed if the
patient does not find it helpful. However, the investigators do not really have a good idea
of exactly which patients are helped by this, and which are not, and just how much their
symptoms are helped, as well as how long the treatment helps them for.
The Eustachian tube is a tube that connects the back of the nose with the ear. Its job is to
keep the pressure on the inside of the eardrum close to the pressure outside the eardrum, so
that the eardrum can vibrate properly. Usually this tube is closed, but it opens briefly
during swallowing. In the condition called patulous eustachian tube, this tube is open all
the time. This is a benign condition but it can be very bothersome to patients.1 The
incidence of patulous Eustachian tube dysfunction is about 0.3-6.6% of the population.
However, about 15% of the people who have this condition are bothered enough by it that they
seek medical attention. This condition is more common in females than males and is more
common in adults than children.1
Some of the common symptoms of patulous eustachian tube can include roaring tinnitus
synchronous with nasal respiration, audible respiratory sounds, sensation of a plugged ear
and fluctuating aural fullness.
In most cases the cause is idiopathic. Some predisposing factors include weight loss,
stress,anxiety,fatigue, pregnancy, and temporomandibular joint syndrome. It can also be
caused by adhesions in the nasopharynx following surgery on the adenoids. Sometimes it can
be associated with medications such as diuretics and oral contraceptives. Neuromuscular
disorders that cause atrophy such as multiple sclerosis, stroke and motor neuron disease
have also been postulated to cause patulous eustachian tube.1 -2
The purpose of this trial is to learn more about the condition and help us learn about how
the eardrum might be treated to prevent it vibrating with sounds or noises coming up the
Eustachian tube.
The first part of the study will consist of a questionnaire to help to further define the
symptoms of patulous eustachian tube, and to measure how severe these symptoms are.
Currently there are few treatments that are satisfactory for patients. Common surgical
therapies include injections of various substances into the Eustachian tube opening
including paraffin, Teflon,or gelfoam. Unfortunately, these methods are either temporary or
have lead to serious complications including cerebral thrombosis and death (due to
inadvertent injection into the carotid artery). Other treatments have focused on cauterizing
the Eustachian tube opening but these have been either unsatisfactory or caused damage to
the trigeminal nerve. Myringotomy and insertion of a ventilation tube has helped some
patients but others have found that this increased the patient's discomfort.3-4
We have been treating patients recently by placing some putty like clay material on the
eardrum, which stops it vibrating so much with the patient's own voice, and this appears to
be quite effective for many patients. It is also easily removed if the patient does not find
it helpful. However, we do not really have a good idea of exactly which patients are helped
by this, and which are not, and just how much their symptoms are helped, as well as how long
the treatment helps them for.
We have not found any permanent hearing loss from putting the putty on the eardrum.
Subject Selection:
There will be approximately twenty patients in total. The absolute number will depend on the
number of patients that present with patulous eustachian tube and agree to participate. All
patients will have been referred to our clinic from other otolaryngologists for treatment of
this particular problem. These patients will be selected if they meet the diagnostic
criteria for patulous eustachian tube. There will be no exclusion criteria based on age or
gender.
Research Plan There will be no randomization procedure, as all patients will receive
treatment for their condition. The investigators will not be blinded, as they are the only
ones able to perform the treatment.
The patients will be asked to follow up in clinic as per his regular visit protocol. They
are usually booked for four-month follow up appointments. If they have concerns they will be
asked to call and book an appointment for an earlier date.
There will be no laboratory testing. The amount of clay to be used is the amount to cover
the size of a dime. If there are any concerns or adverse reactions to treatment the patient
will have the treatment stopped. The clay or steristrip will be removed.
Analysis of Data The data will be compiled and sent to a member of the statistics department
at Dalhousie University. All identifying data will be removed. The pre-treatment values will
then be compared to post treatment values to see if a statistical significance exists.
Confidentiality All data will kept in a locked filing cabinet and office for 25 years, and
only research staff will have access to it. The data will be analyzed using various computer
programs, such as Gaitview 2002, Microsoft Office programs, and SPSS for statistical
analysis. The data on these programs will only be available to research staff via a secure
password. Names of patients will only be available to research staff, and numerical codes
will be used in any presentations or publications of the data. The research team will
collect and use only the information they need to judge the safety and usefulness of the
study. This information will only be used for the purposes of this study.
Only Dr.Bance and Dr.Bartlett will have access to the study data.
Harms There are very few risks to this trial. It is generally a well-tolerated procedure.
The biggest risk is failure of the procedure. It does not work for everyone.
The laser measurements of the eardrum are without risk. This laser does not damage tissue.
Putting the steri-strip or clay weight on the eardrum may carry about a 1 in 300 risk of a
small puncture to the eardrum. Of these, over 95% heal up by themselves, but some may need
to be repaired. This, however, is currently our preferred first line treatment for patulous
Eustachian tube currently anyway.
Benefits
There is no financial incentive to join the trial. The major benefit will be a potential
resolution of the symptoms of patulous eustachian tube.
The societal benefits are an easy safe treatment for this condition.
Financial Compensation
There is no financial compensation for anyone involved in this trial. This includes
participants and researchers.
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Observational Model: Cohort, Time Perspective: Retrospective