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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00933478
First received: July 6, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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 Intervention
Patulous Eustachian Tube Dysfunction
Device: Clay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Amount recorded improvement with treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
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)
Groups/Cohorts Assigned Interventions
Patients with Patulous Eustachian Tube Dysfunction Device: Clay
Small dime sized piece of clay.
Other Name: Clay is used is Blue tac.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients will be selected if they meet the diagnostic criteria for patulous eustachian tube.

Criteria

Inclusion Criteria:

  • presence of condition (patulous eustachian tube dysfunction)

Exclusion Criteria:

  • Hole in Tympanic Membrane.
  • Allergy to Blue tac
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933478

Locations
Canada, Nova Scotia
Victoria General Hospital Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Principal Investigator: Clark G Bartlett, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Clark G Bartlett, MD Dalhousie Department of Otolaryngology
  More Information

Publications:
Responsible Party: Dr.Clark Bartlett, Dalhousie University Department of Otolaryngology
ClinicalTrials.gov Identifier: NCT00933478     History of Changes
Other Study ID Numbers: Clark Bartlett
Study First Received: July 6, 2009
Last Updated: July 7, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
Patulous Eustachian Tube Dysfunction

ClinicalTrials.gov processed this record on July 28, 2014