View clinical trials related to Eustachian Tube Dysfunction.
Filter by:To date, more than 130 000 Balloon Eustachian Tuboplasty (BET) procedures have been performed worldwide. This procedure is proposed in case of Obstructive Eustachian Tube Dysfunction (OETD) with or without chronic otitis media. However, the effectiveness of this procedure is still discussed amongst otolaryngologist. Most of studies,were open label prospective studies comparing Eustachian tube function before and after surgical treatment. A recent meta-analysis suggests that BET procedure improves postoperative Eustachian tube function, but high-level evidence is still lacking. In this project, the investigators propose to perform the first blinded randomized controlled trial procedure to assess the changes of Eustachian tube function after BET in a population of subjects with chronic OETD with or without chronic otitis. Prognosis factors of efficacy will be also investigated during the study.
The Eustachian tube (ET) connects the middle ear with the throat and is important for maintaining a healthy middle ear. Sonotubometry is a new method to measure how well the ET works by using sound. A speaker is placed at the nostril and a microphone records sound in the external ear canal. The ET is closed at rest and opens with swallowing. This is measured as an increase in sound measured in the external ear by sonotubometry. Previous research has not proven that sonotubometry is reliable enough to be used in clinics to assess ET dysfunction (a disease where the ET does not open properly). In a recent study with healthy volunteers, it was possible to identify many of the existing issues of sonotubometry and improve the reliability of this method. This was primarily achieved by testing different sound types and sound volumes. This study aims to assess the reliability and usability of the new testing protocol in study participants with ET dysfunction. The results of this study will then be compared with the results from the previous study with healthy volunteers to work out how well sonotubometry works. Ultimately, this research aims to improve the ability to diagnose ET dysfunction.
This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals: 1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction 2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube 3. Re-demonstrate the safety of balloon dilation of the eustachian tube What does participation in this study involve? Participants in this study will: - Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later - Agree to allowing the investigators access to their personal health information - Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure: - A questionnaire to assess your eustachian tube dysfunction - An assessment of the movement of your ear drum (tympanogram) - A hearing test (audiogram) - A questionnaire to assess the impact of eustachian tube dysfunction on work/activity - A questionnaire to assess overall health-related quality of life - An assessment of the ability to equalize middle ear pressure(s) - Visual examination of the ear drums - Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 12-, 24-, and 52-weeks after the procedure.
This study aims to evaluate and screen out the factors related to the improvement of eustachian tube function after adenoidectomy and/or tonsillectomy, so as to guide the treatment of children's eustachian tube function before and after operation, and provide the treatment direction and methods for diseases related to eustachian tube dysfunction for people with adenoid hypertrophy and/or tonsil hypertrophy complicated with ETD.
Intranasal nasal steroid sprays are the mainstay of treatment for chronic Eustachian tube dysfunction despite having little supportive evidence in the literature. A novel, commercially available nasal spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).
In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
The eustachian tube (ET) performs three primary functions: pressure equalisation between the nasopharyms and middle ear: clearance of mucus from the middle ear, and prevention of sound or fluid reflux from the nasopharynx(1) .In individuals suffering from custachian tube dysunction (ETD), the tube opening may be obstructed(2) resulting in the typical complaints of ear fullness, muffled hearing, or tinnitus(3). Less frequently, the ET may be permanently patulous, resulting in the symptoms of aural pressure or autophony (4). Adequate Eustachian tube function (ETF) is necessary for successful middle ear surgery. Studies of eustachian tube patency have been studied by the Politzer, Valsalva, and Toynbee maneuvers. In other cases it has been accomplished by testing air transport through the eustachian tube by tympanometry, sonotubometry, and air pressure equalization technique. However, these methods do not evaluate the drainage function (5). Saccharin is a nonnutritive sweetener. It has property of being inert to respiratory epithelium that is it does not hamper physiological mucus clearance of sino-nasal mucosa. It can be used to assess mucocilliary function of nasal mucosa, without itself hampering it. The saccharin test seems to provide adequate information of the mucociliary function and patency of the ET (6) . Methylene blue is a chemical compound. It can be used to check patency of (ET). The dye, because of its liquid form, gravitates through the ET to the nasopharynx. So the objective of the dye is to establish the anatomical presence or absence of tube patency.
This is Prospective Basic Science Study whose aims are as follows: 1. To determine the effect of Filtering Facepiece (FFP3M) respirators on eustachian tube function and hearing 2. To evaluate the extent to which FFP3M respirators attenuate speech in decibels The outcome measures are as follows: 1. Changes in baseline pure tone audiometry and tympanometry post intervention. 2. SNOT-22 Questionnaires before and after use of respirator 3. ETDQ7 questionnaire 4. Measurement of speech attenuation in decibels.
Background: The Eustachian Tube (ET) is a mucosa-lined connection between the nasopharynx and the middle ear cavity. It is believed to have three functions: 1) ventilation of and pressure equalization in the middle ear cavity, 2) mucus drainage from the middle ear, and 3) protection against sound and infection from the nasopharynx1. In adults, Eustachian Tube Dysfunction (ETD) can cause complaints from one or both ears. For many years, various definitions of ETD have been used, impairing the opportunity to compare studies. However, in 2015, an international consensus on definition, types, clinical presentation, and diagnosis of ETD was published by Schilder et al2, which has been adopted by all the Scandinavian countries. The symptoms include pressure (fullness), and/or pain in the ear, muffled hearing, and overall discomfort. Furthermore, chronic ETD can result in tympanic membrane retraction, atelectasis of the middle ear cavity, and ultimately formation of cholesteatoma3. Unfortunately, the symptoms of ETD are multiple and inaccurate giving rise to varying estimates of the prevalence. As an example, a study in UK found a 0.9 % prevalence of ETD4. In addition, clear guidelines on diagnostics and treatment are not currently available due to the fact, that no objective test for detection of ETD exists. In the need of a symptom scoring system, the patient reported Eustachian Tube Dysfunction Questionnaire (ETDQ-7) has been developed and validated in English5. Yet, translation into other languages as well as validation in other settings are necessary in order to substantiate the applicability of ETDQ-7. ETD is associated with a lack of opening of ET. It is believed that the length, diameter and angle of ET influences its ability to open regularly, thus affecting its function. A short, narrow and angled ET may predispose to ETD. However, the imaging available to visualize ET are not accurate enough to diagnose ETD. A direct test of the function of ET is not available. Tubomanometry is a relatively new method developed to directly test the opening of ET, but is yet to be validated6. Both non-surgical and surgical treatment options to improve the function of the Eustachian Tube are available. Non-surgical management includes pressure equalization methods (e.g. the Valsalva maneuver), antihistamines, treatment with decongestants, and nasal douching with a saline solution. Surgically, ventilation tubes are often used to treat ETD. In case of adenoid hypertrophy obstructing the pharyngeal opening of ET, adenoidectomy is recommended. Balloon Eustachian Tuboplasty (BET) was introduced in 2010 by Ockermann et al7. BET is a non-invasive procedure performed under general anesthesia. During the procedure, a catheter is inserted either endonasally or transtympanic into ET, and a balloon is inflated with water for approximately two minutes. Various heterogeneous studies have shown a short-term effect of BET, but long-term effects are unclear8. In summary, despite the assumption of being a common condition, the field of ETD suffers from lack of precise definition, diagnostic criteria, identification of underlying causes as well as purposeful treatment, and prognostic factors. Especially, long-term effects of BET need further investigation. Therefore, in an effort to fill out the gap of knowledge about ETD, the following specific aims are proposed:
Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.