Patulous Eustachian Tube DysfunctionNCT00933478
A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube
An observational study of Patulous Eustachian Tube Dysfunction, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patulous Eustachian Tube Dysfunction
- What is being tested?
- Clay
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jul 2010
- Phase
- Observational
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be selected if they meet the diagnostic criteria for patulous eustachian tube.
Who may be able to join
- presence of condition (patulous eustachian tube dysfunction)
Who cannot join
- Hole in Tympanic Membrane.
- Allergy to Blue tac
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Patulous Eustachian Tube Dysfunction
- Being tested
- Clay
- Keywords
- Patulous Eustachian Tube Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClayDevice
Also called Clay is used is Blue tac.
Small dime sized piece of clay.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Patulous Eustachian Tube Dysfunction | Not described Receives: Device: Clay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount recorded improvement with treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009 (estimated)
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Why it stopped: NSH REB has no record of this study being submitted for review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patulous Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clark G Bartlett, MD, Principal investigator, Dalhousie Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933478
- Sponsor's protocol ID
- Clark Bartlett
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connor AF, Shea JJ. Autophony and the patulous eustachian tube. Laryngoscope. 1981 Sep;91(9 Pt 1):1427-35. doi: 10.1288/00005537-198109000-00003.
PubMed 7346684Virtanen H, Palva T. Surgical treatment of patulous eustachian tube. Arch Otolaryngol. 1982 Nov;108(11):735-9. doi: 10.1001/archotol.1982.00790590057016.
PubMed 7138369Sehhati-Chafai-Leuwer S, Wenzel S, Bschorer R, Seedorf H, Kucinski T, Maier H, Leuwer R. Pathophysiology of the Eustachian tube--relevant new aspects for the head and neck surgeon. J Craniomaxillofac Surg. 2006 Sep;34(6):351-4. doi: 10.1016/j.jcms.2006.03.006. Epub 2006 Jul 21.
PubMed 16859910Cairns W. The patulous Eustachian tube syndrome. Palliat Med. 1998 Jan;12(1):59-60. doi: 10.1191/026921698671963177. No abstract available.
PubMed 9616461
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube
- ClinicalTrials.gov ID
- NCT00933478
- Acronym / sponsor ID
- Clark Bartlett
- Conditions
- Patulous Eustachian Tube Dysfunction
- Keywords
- Patulous Eustachian Tube Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: NSH REB has no record of this study being submitted for review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2009 (estimated)
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 7 Jul 2009 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Patulous Eustachian Tube Dysfunction | – | Device: Clay |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be selected if they meet the diagnostic criteria for patulous eustachian tube.
Key inclusion criteria (1 listed)
- presence of condition (patulous eustachian tube dysfunction)
Key exclusion criteria (2 listed)
- Hole in Tympanic Membrane.
- Allergy to Blue tac
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 |
|---|---|---|
| ClayAlso: Clay is used is Blue tac.Small dime sized piece of clay. | Device | Patients with Patulous Eustachian Tube Dysfunction |
Primary outcome
Amount recorded improvement with treatment
Time frame: 1 year
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 21 Aug 2024.
- Background: PubMed 7346684O'Connor AF, Shea JJ. Autophony and the patulous eustachian tube. Laryngoscope. 1981 Sep;91(9 Pt 1):1427-35. doi: 10.1288/00005537-198109000-00003.
- Background: PubMed 7138369Virtanen H, Palva T. Surgical treatment of patulous eustachian tube. Arch Otolaryngol. 1982 Nov;108(11):735-9. doi: 10.1001/archotol.1982.00790590057016.
- Background: PubMed 16859910Sehhati-Chafai-Leuwer S, Wenzel S, Bschorer R, Seedorf H, Kucinski T, Maier H, Leuwer R. Pathophysiology of the Eustachian tube--relevant new aspects for the head and neck surgeon. J Craniomaxillofac Surg. 2006 Sep;34(6):351-4. doi: 10.1016/j.jcms.2006.03.006. Epub 2006 Jul 21.
- Results publication: PubMed 9616461Cairns W. The patulous Eustachian tube syndrome. Palliat Med. 1998 Jan;12(1):59-60. doi: 10.1191/026921698671963177. No abstract available.
Related trials for Patulous Eustachian Tube Dysfunction
Recruiting
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
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.
Clark G Bartlett, MD principal investigator
Dalhousie Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patulous Eustachian Tube Dysfunction, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 2 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 21 Aug 2024. 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 Canada. 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?
Amount recorded improvement with treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933478, which also lists 4 linked publications.
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 21 Aug 2024.