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A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933478
Recruitment Status : Unknown
Verified July 2009 by Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2009
Last Update Posted : July 8, 2009
Information provided by:
Nova Scotia Health Authority

Brief Summary:

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.

Condition or disease Intervention/treatment
Patulous Eustachian Tube Dysfunction Device: Clay

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube
Study Start Date : July 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Group/Cohort Intervention/treatment
Patients with Patulous Eustachian Tube Dysfunction Device: Clay
Small dime sized piece of clay.
Other Name: Clay is used is Blue tac.

Primary Outcome Measures :
  1. Amount recorded improvement with treatment [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be selected if they meet the diagnostic criteria for patulous eustachian tube.

Inclusion Criteria:

  • presence of condition (patulous eustachian tube dysfunction)

Exclusion Criteria:

  • Hole in Tympanic Membrane.
  • Allergy to Blue tac

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933478

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Canada, Nova Scotia
Victoria General Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
Principal Investigator: Clark G Bartlett, MD         
Sponsors and Collaborators
Nova Scotia Health Authority
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Principal Investigator: Clark G Bartlett, MD Dalhousie Department of Otolaryngology
Publications of Results:
Other Publications:
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Responsible Party: Dr.Clark Bartlett, Dalhousie University Department of Otolaryngology Identifier: NCT00933478    
Other Study ID Numbers: Clark Bartlett
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009
Keywords provided by Nova Scotia Health Authority:
Patulous Eustachian Tube Dysfunction