Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 3

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.