Clinical trial NCT01974726: Gas Supply, Demand and Middle Ear Gas Balance -- Diagnosis of Eustachian Tube Dysfunction
Official title: Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Keywords: ear
middle ear
Eustachian tube
Eustachian tube dysfunction
Eustachian tube function
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-11-01
Enrollment: 95
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: ETF tests
timeFrame: 2 years (affecteds), 1 week (controls)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Middle Ear Physiology Laboratory
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Cuneyt M Alper, MD
role: PRINCIPAL_INVESTIGATOR
References: