A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube
Recruitment status was: Not yet recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube|
- Amount recorded improvement with treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Patients with Patulous Eustachian Tube Dysfunction||
Small dime sized piece of clay.
Other Name: Clay is used is Blue tac.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00933478
|Canada, Nova Scotia|
|Victoria General Hospital|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Principal Investigator:||Clark G Bartlett, MD||Dalhousie Department of Otolaryngology|