Gas Supply, Demand and Middle Ear Gas Balance -- Diagnosis of Eustachian Tube Dysfunction
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 3 - 70 |
| Updated: | 10/17/2018 |
| Start Date: | October 2013 |
| End Date: | July 2019 |
| Contact: | Julie Banks, BS |
| Email: | juliane.banks@chp.edu |
| Phone: | 412-692-3595 |
Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 3
The aim of this study is to determine which of the many Eustachian tube function tests (or
combination of tests) is most helpful in finding out what is causing ear problems in children
and adult patients with middle-ear diseases thought to be due to poor Eustachian tube
function. The Eustachian tube is a biological tube that connects the middle ear to the back
of the nose and throat. When the Eustachian tube works normally, it opens and closes to help
keep the pressure in the middle ear the same as room air-pressure (atmospheric pressure).
When the Eustachian tube does not work well, the pressure in the middle ear can increase or
decrease and feel like a blocked ear or cause ear pain. Poor Eustachian tube function can be
associated with distressing middle-ear symptoms, predispose to middle-ear problems under
conditions of rapidly changing air pressures such as occur during airflight and diving, and
cause certain middle-ear diseases such as otitis media with effusion. It is also known that
the results for the most commonly used Eustachian tube function tests in adults and children
with various middle-ear diseases are poorer when compared to children and adults without
middle-ear diseases. However, knowing that there is a difference in test results between
groups with and without disease does not mean that any of those tests provide information
useful in the management of individual patients with diseases due to Eustachian tube
function. To be useful clinically, a test(s) that can accurately identify patients with a
level of poor Eustachian tube function sufficient to cause middle-ear symptoms and signs
and/or cause middle-ear disease is needed. To be very useful, tests should be able to
diagnose the cause of any observed Eustachian tube problem so that treatment for that problem
could be begun. The investigators would also want tests that could predict whether or not the
ear disease will resolve with (or without) treatment and whether or not certain surgical
procedures for middle-ear problems will be successful. Here, a number of Eustachian tube
function tests are being used to diagnose and characterize the cause of Eustachian tube
dysfunction in children and adults presenting to the research clinic with suspected poor
Eustachian tube function and/or a recent history of middle-ear disease that can be caused by
poor Eustachian tube function. After the testing, medical records will be periodically
reviewed for 2 years and study participants will be contacted by phone to obtain information
on their middle-ear disease, the response of the disease to any treatments and the
success/failure of any surgical procedures used to fix middle-ear problems.
Because this study focuses on evaluating the potential usefulness of Eustachian tube function
testing for the diagnosis of Eustachian tube dysfunction and, if present, its cause, no
specific treatments or surgical interventions are included in this study or recommended by
the investigators. These decisions are left to the subject-patient in consultation with their
doctor.
To further evaluate the Eustachian function tests, a control group of healthy adults without
a history of middle-ear problems will undergo testing at two separate sessions; these
subjects will have no further follow-up.
combination of tests) is most helpful in finding out what is causing ear problems in children
and adult patients with middle-ear diseases thought to be due to poor Eustachian tube
function. The Eustachian tube is a biological tube that connects the middle ear to the back
of the nose and throat. When the Eustachian tube works normally, it opens and closes to help
keep the pressure in the middle ear the same as room air-pressure (atmospheric pressure).
When the Eustachian tube does not work well, the pressure in the middle ear can increase or
decrease and feel like a blocked ear or cause ear pain. Poor Eustachian tube function can be
associated with distressing middle-ear symptoms, predispose to middle-ear problems under
conditions of rapidly changing air pressures such as occur during airflight and diving, and
cause certain middle-ear diseases such as otitis media with effusion. It is also known that
the results for the most commonly used Eustachian tube function tests in adults and children
with various middle-ear diseases are poorer when compared to children and adults without
middle-ear diseases. However, knowing that there is a difference in test results between
groups with and without disease does not mean that any of those tests provide information
useful in the management of individual patients with diseases due to Eustachian tube
function. To be useful clinically, a test(s) that can accurately identify patients with a
level of poor Eustachian tube function sufficient to cause middle-ear symptoms and signs
and/or cause middle-ear disease is needed. To be very useful, tests should be able to
diagnose the cause of any observed Eustachian tube problem so that treatment for that problem
could be begun. The investigators would also want tests that could predict whether or not the
ear disease will resolve with (or without) treatment and whether or not certain surgical
procedures for middle-ear problems will be successful. Here, a number of Eustachian tube
function tests are being used to diagnose and characterize the cause of Eustachian tube
dysfunction in children and adults presenting to the research clinic with suspected poor
Eustachian tube function and/or a recent history of middle-ear disease that can be caused by
poor Eustachian tube function. After the testing, medical records will be periodically
reviewed for 2 years and study participants will be contacted by phone to obtain information
on their middle-ear disease, the response of the disease to any treatments and the
success/failure of any surgical procedures used to fix middle-ear problems.
Because this study focuses on evaluating the potential usefulness of Eustachian tube function
testing for the diagnosis of Eustachian tube dysfunction and, if present, its cause, no
specific treatments or surgical interventions are included in this study or recommended by
the investigators. These decisions are left to the subject-patient in consultation with their
doctor.
To further evaluate the Eustachian function tests, a control group of healthy adults without
a history of middle-ear problems will undergo testing at two separate sessions; these
subjects will have no further follow-up.
The overall objective is to develop the clinical utility of a panel of new and existing
Eustachian Tube Function (ETF) tests with respect to diagnosing ET dysfunction and its cause,
recommending specific targeted interventions to re-establish normal function and predicting
the future course of diseases attributable to that dysfunction.
In this Protocol, the investigators open their research center to the clinical evaluation of
all physician or self-referred children and adults with suspected ET dysfunction (ETD)and/or
diseases attributable to that dysfunction, perform a broad panel of ETF tests to diagnose the
presence/absence and cause of the dysfunction and then collect from patient records
information on the future disease course in those subjects to begin developing a
comprehensive database relevant to clinical utility of the various tests. An adult control
group consisting of healthy volunteers without a history of significant middle-ear disease
will also be entered.
ETF will be evaluated in this highly heterogeneous population using a pressure-chamber
protocol (ET stress test), a panel of other tests as is relevant to the status of the
tympanic membrane and, in older subjects (10 years and older, or younger if tolerated),
endoscopic assessments of nasopharyngeal pathologies. The goal of this study is to define the
least costly panel of test procedures that is sensitive, specific and accurate for the
diagnosis of ETD, identification of the cause of the dysfunction if observed, prediction of
the success rates for medical or surgical interventions (e.g. the newer ET surgical
procedures, adenoidectomy, myringoplasty) and prediction of future disease course
(probability of spontaneous resolution). These results will be interpreted in terms of
whether or not ETF testing is of practical value to clinicians in their decision-making
related to ETD, otitis media with effusion (OME) and chronic OME (COME) and if relatively
portable, inexpensive test systems with the listed properties can be introduced into a
typical physician's practice.
All entered patients/subjects with a history of middle-ear disease will have an initial
history taken with a focus on predisposing factors for ETD and OME (e.g. atopy, recent or
frequent colds, gastroesophageal reflux disease, etc.) and on the symptoms and signs
associated with the initial presentation of the condition. A standard clinical ear, nose and
throat (ENT) examination with pneumatic otoscopy and tympanometry (if possible) will be done.
Subjects with extant middle-ear (ME) effusion or otorrhea through a tube or with signs or
symptoms of a cold or allergic rhinitis will not be tested, but may be studied at a later
time upon resolution of the condition. Patients with no contraindications to the planned test
panel will be triaged to one of the two standard ETF test panels used in our laboratory, 1)
the Maneuver Sequence, sonotubometry, tubomanometry, the Forced-Response test, the
Inflation-Deflation test and the ET stress test if presenting with a tympanic membrane
perforation/ventilation tube, or 2) the Maneuver Sequence, sonotubometry, tubomanometry,
9-step test and the the ET stress test if presenting with an intact tympanic membrane. The
investigators begin with these tests because they capture a global assessment of ETF with
respect to: the muscle-assisted ET opening efficiency which is a measure of ME
pressure-regulation and the patency of the ET which is a measure of the protective function
of the ET (patulous, semi-patulous, obstructed). For all subjects aged 10 years and older and
any younger subject who is sufficiently cooperative, the investigators will perform
nasoendoscopic evaluations of the nasopharynx and ET orifice at rest and during swallowing,
speech and other maneuvers to determine if there is a detectable extrinsic cause of the ETD.
A summary diagnosis of the presence/absence and the type and cause of the ETD (if any) will
be prepared by the study physician, and, if a referred patient, submitted to the referring
physician or, if self-presenting, to the subject's Primary Care Physician (PCP). Every 6
months for 2 years, the subjects or their parents (if minors) will be contacted to update
their medical history, and the subject's medical charts will be requested and reviewed once a
year for 2 years to update the Center's database with respect to the subject's disease course
and the outcome of any surgeries or treatments.
The adult control subjects will undergo similar ET function testing as the affected group and
nasoendoscopic evaluation. These will be repeated at one other test session at least 1 week
after the first testing and there will be no further follow-up of these subjects.
Using the control data from parallel studies, the control subjects in this protocol and the
subjects' history with respect to ME complaints, the evaluations of ETF, the feedback from
subjects and the review of medical records, the investigators expect to develop an algorithm
that prescribes the specific test sequences that optimize the diagnosis of the type and cause
of ETD and the treatment recommendations for a given patient presenting with a specific
history and set of ETD signs and/or symptoms. The investigators also expect to establish,
with reasonable certainty, whether or not the results of these tests are clinically useful to
otolaryngologists and general practitioners in their decision-making with respect to
prescribed treatments and/or surgical interventions for affected patients. For each test or
panel of tests, the investigators will define their sensitivity, specificity and accuracy
with respect to the various outcomes.
Eustachian Tube Function (ETF) tests with respect to diagnosing ET dysfunction and its cause,
recommending specific targeted interventions to re-establish normal function and predicting
the future course of diseases attributable to that dysfunction.
In this Protocol, the investigators open their research center to the clinical evaluation of
all physician or self-referred children and adults with suspected ET dysfunction (ETD)and/or
diseases attributable to that dysfunction, perform a broad panel of ETF tests to diagnose the
presence/absence and cause of the dysfunction and then collect from patient records
information on the future disease course in those subjects to begin developing a
comprehensive database relevant to clinical utility of the various tests. An adult control
group consisting of healthy volunteers without a history of significant middle-ear disease
will also be entered.
ETF will be evaluated in this highly heterogeneous population using a pressure-chamber
protocol (ET stress test), a panel of other tests as is relevant to the status of the
tympanic membrane and, in older subjects (10 years and older, or younger if tolerated),
endoscopic assessments of nasopharyngeal pathologies. The goal of this study is to define the
least costly panel of test procedures that is sensitive, specific and accurate for the
diagnosis of ETD, identification of the cause of the dysfunction if observed, prediction of
the success rates for medical or surgical interventions (e.g. the newer ET surgical
procedures, adenoidectomy, myringoplasty) and prediction of future disease course
(probability of spontaneous resolution). These results will be interpreted in terms of
whether or not ETF testing is of practical value to clinicians in their decision-making
related to ETD, otitis media with effusion (OME) and chronic OME (COME) and if relatively
portable, inexpensive test systems with the listed properties can be introduced into a
typical physician's practice.
All entered patients/subjects with a history of middle-ear disease will have an initial
history taken with a focus on predisposing factors for ETD and OME (e.g. atopy, recent or
frequent colds, gastroesophageal reflux disease, etc.) and on the symptoms and signs
associated with the initial presentation of the condition. A standard clinical ear, nose and
throat (ENT) examination with pneumatic otoscopy and tympanometry (if possible) will be done.
Subjects with extant middle-ear (ME) effusion or otorrhea through a tube or with signs or
symptoms of a cold or allergic rhinitis will not be tested, but may be studied at a later
time upon resolution of the condition. Patients with no contraindications to the planned test
panel will be triaged to one of the two standard ETF test panels used in our laboratory, 1)
the Maneuver Sequence, sonotubometry, tubomanometry, the Forced-Response test, the
Inflation-Deflation test and the ET stress test if presenting with a tympanic membrane
perforation/ventilation tube, or 2) the Maneuver Sequence, sonotubometry, tubomanometry,
9-step test and the the ET stress test if presenting with an intact tympanic membrane. The
investigators begin with these tests because they capture a global assessment of ETF with
respect to: the muscle-assisted ET opening efficiency which is a measure of ME
pressure-regulation and the patency of the ET which is a measure of the protective function
of the ET (patulous, semi-patulous, obstructed). For all subjects aged 10 years and older and
any younger subject who is sufficiently cooperative, the investigators will perform
nasoendoscopic evaluations of the nasopharynx and ET orifice at rest and during swallowing,
speech and other maneuvers to determine if there is a detectable extrinsic cause of the ETD.
A summary diagnosis of the presence/absence and the type and cause of the ETD (if any) will
be prepared by the study physician, and, if a referred patient, submitted to the referring
physician or, if self-presenting, to the subject's Primary Care Physician (PCP). Every 6
months for 2 years, the subjects or their parents (if minors) will be contacted to update
their medical history, and the subject's medical charts will be requested and reviewed once a
year for 2 years to update the Center's database with respect to the subject's disease course
and the outcome of any surgeries or treatments.
The adult control subjects will undergo similar ET function testing as the affected group and
nasoendoscopic evaluation. These will be repeated at one other test session at least 1 week
after the first testing and there will be no further follow-up of these subjects.
Using the control data from parallel studies, the control subjects in this protocol and the
subjects' history with respect to ME complaints, the evaluations of ETF, the feedback from
subjects and the review of medical records, the investigators expect to develop an algorithm
that prescribes the specific test sequences that optimize the diagnosis of the type and cause
of ETD and the treatment recommendations for a given patient presenting with a specific
history and set of ETD signs and/or symptoms. The investigators also expect to establish,
with reasonable certainty, whether or not the results of these tests are clinically useful to
otolaryngologists and general practitioners in their decision-making with respect to
prescribed treatments and/or surgical interventions for affected patients. For each test or
panel of tests, the investigators will define their sensitivity, specificity and accuracy
with respect to the various outcomes.
AFFECTED SUBJECTS:
Inclusion Criteria:
- 3-70 years of age
- Diagnosed or suspected Eustachian tube dysfunction or middle-ear disease
- Able to read and comprehend English
Exclusion Criteria:
- Extant middle-ear effusion, allergic rhinitis or "cold" (may enter when resolved)
- History of ossicular reconstruction
- Blood pressure greater than or equal to 140/90 (adults)
- Recent angina; history of heart attack, stroke, cardiac surgery or any other medical
condition that the study physician deems entry not in the subject's best interest.
CONTROL SUBJECTS
Inclusion Criteria:
- 18 -60 years of age
- Generally healthy
- No history of middle-ear disease
- Intact or non-intact tympanic membrane -- perforation or tube for reasons other than
middle-ear disease.
Exclusion Criteria:
- Extant middle-ear effusion, allergic rhinitis or "cold" (may enter when resolved)
- History of ossicular reconstruction
- Blood pressure greater than or equal to 140/90
- Sensitivity to drugs used for endoscopy (lidocaine, oxymetazoline)
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