8 Clinical Trials for Various Conditions
Elevation of the soft palate (the soft part of the roof of the mouth) during swallowing helps the Eustachian tube to open and keep the ear healthy. (The Eustachian tube is the normal tube running from the middle ear to the back of the nose and throat). When the soft palate does not move enough (due to a history of cleft palate or for unknown reasons), this can lead to speech problems. Also, because the Eustachian tube is not opening enough, fluid can accumulate in the middle ear, which requires treatment with ear tubes. The goal of this research study is to determine if soft palate exercises will help improve the ability of the soft palate to close the area between the throat and nose, like it is supposed to during speech and swallowing, and if this improves Eustachian tube opening.
This study is an investigation into the effect that CPAP has on the pressure in the middle ear. It will evaluate the middle ear pressure and ear drum appearance at multiple levels of CPAP pressure delivered via a full face mask. These measurements will be used to determine optimal levels of CPAP to affect individual's middle ear pressure, particularly those with negative middle ear pressure due to Eustachian tube dysfunction.
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.
The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. The investigators randomly assigned patient-treatment group exposures to four different time interval and rate (slope) of compression. These total time intervals of compression and rates (slopes) of compression are identical to those used in the Phase I trial. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the 4 compression schedules, similar to ther Phase I trial will be recorded. Patients who are symptomatic and require compression stops (as in the Phase I trial) using a United States Navy Treatment Table 9 (USN-TTN9) during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be analyzed. Analysis using descriptive and inferential statistics will be applied to the patients requiring first stops in the 4 compression profiles. This Phase II study increases the sample size of treatments and they will be combined with the total number of treatments used in the original phase I study. This will increase power to facilitate detailed descriptive analysis and to determine if the findings are robust in the phase I study.
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.
This study will test the hypothesis that constitutionally poorer Eustachian tube function predisposes to middle-ear pathology during a viral upper respiratory infection.
The middle ear is an airspace located behind the eardrum that consists of two connecting compartments. The compartment directly behind the eardrum is called the tympanum and contains the three small bones of the middle ear, the hammer, anvil and stapes, that function to transfer eardrum movements to the inner ear so that you can hear. Behind the tympanum is the mastoid cavity which is a larger airspace subdivided into small air cells of unknown function. For normal hearing, it is important that the air pressure in the middle ear is similar to that of the environment so that the eardrum can move freely in response to sounds. The air pressure of the environment is not constant and is affected by changes in weather conditions (high and low pressure systems that move through the area) and by changes in elevation above sea level (the fullness in your ears that can be noticed when you ride in an elevator or in an airplane). The air pressure in the middle ear also changes because middle ear gas is constantly leaking from that airspace to the blood that flows through the walls of the middle ear. These effects (changing environmental air pressures and changing middle ear air pressure) are independent and cause the middle ear and environmental pressures to be different from each other. Periodically and during swallowing or yawning, any existing difference between middle ear and environmental air pressure is reset to zero by the opening of a biological tube (the Eustachian tube) that connects the middle ear to the back of the nose. This allows gas flow between the middle ear and the environment which increases or decreases middle ear pressure to the level in the environment at that time. Most people cannot open their Eustachian tubes at will and the number of automatic openings varies from infrequent to often in a population. Whether or not a person's usual frequency of Eustachian openings is good enough to keep the middle ear pressure the same as environmental levels depends on how fast gas is lost from the middle ear by gas leakage (diffusion) to blood. For example, in ears with very slow rates of gas loss, the Eustachian tube does not need to open very frequently to keep the middle ear at environmental pressure. Some researchers believe that the mastoid compartment functions to control the rate of gas loss to blood, with larger mastoid volumes associated with lesser rates of middle ear gas loss. In this experiment, the investigators plan to test this by measuring mastoid and tympanum volumes using Computer tomography (CT) and the rate of blood to middle ear gas transfer using a technique that involves breathing air that contains laughing gas (Nitrous Oxide=N2O) and measuring middle ear pressure change using tympanometry (a technique that involves putting an ear plug into the ear canal and measuring the pressure). From past studies in patients undergoing short surgical or dental procedures, the investigators know that breathing gas mixtures that contain N2O will increase the blood levels of that gas, cause gas to go from blood to the middle ear and increase middle ear pressure. The investigators predict that the rate of change in middle ear pressure while breathing a gas mixture containing 25% N2O and the normal oxygen level (20%) of air will be less for those ears with larger mastoid volumes. If the investigators prediction is correct, they will be able to explain why ears with larger mastoid volumes are better able to keep their pressure like that of the environment even if the Eustachian tube does not open often.