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Showing 1-20 of 26 trials
NCT07242001
The goal of this clinical trial is to learn if laser acupuncture (LA) can improve middle ear function and reduce the recurrence of Otitis Media with Effusion (OME) in children. The main questions it aims to answer are: Does LA, when combined with standard treatment (decongestants), improve middle ear function as measured by tympanometry immediately after the 2-week intervention? Does LA, when combined with standard treatment, reduce the recurrence rate of OME as monitored over a 1-month period after the intervention? What is the safety profile of LA in this population, as measured by the incidence of adverse events? Researchers will compare active LA to sham LA (a placebo procedure with an inactive device) to determine if LA leads to meaningful improvements in children with OME. Participants will: Complete an initial assessment using tympanometry to confirm the diagnosis. Receive four sessions of either active LA or sham LA over a 2-week period. Complete a final assessment using tympanometry after the final session. Participate in a 1-month follow-up period with weekly monitoring for recurrence.
NCT07122999
This randomized controlled trial evaluated the effectiveness of autoinflation in preventing recurrence of otitis media with effusion (OME) and reducing the need for reoperation after tympanostomy tube (TT) extrusion in children. Sixty-six pediatric patients with chronic OME underwent TT placement, and 54 were included in the final analysis. After TT extrusion, participants were randomized into two groups: an autoinflation group using a handheld device (Eustachi) for five weeks, and an observation-only group. Patients were followed for two years post-extrusion, with periodic otoscopic and tympanometric assessments. The autoinflation group showed a lower recurrence rate (19.2%) compared to the observation group (35.7%), although this difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7% vs. 28.6%). Tympanometric findings suggested more stable middle ear pressure in the autoinflation group. These results indicate that autoinflation is a safe, feasible, and non-invasive method that may support eustachian tube function and reduce the need for repeat TT placement in children following TT extrusion.
NCT01202578
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
NCT06316635
Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME.
NCT04395261
The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.
NCT02716376
To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head \& Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.
NCT05449184
The primary purpose of this study is to compare balloon Eustachian tuboplasty (BET) combined with tympanostomy tube insertion and simply tympanostomy tube insertion in the treatment of otitis media with effusion (OME) in post-radiotherapy patients on the improvement of subjective symptoms (ear fullness, etc.) and the tympanogram. The secondary purpose is to clarify the effects of BET on the incidence of middle ear infection and slippage of ventilation tube during tube retention, as well as to determine the difference of hearing improvement between the two management methods.
NCT05402267
The particularity of adenoids, as a reservoir of bacterial pathogens and immune molecules, is known to be significantly involved in children with otitis media with effusion (OME). As an important carrier of intercellular substance transfer and signal transduction, exosomes with different biological functions can be secreted by different types of cells. There remains significant uncertainty regarding the clinical transmitter of exosomes to OME, especially in its pathophysiologic development. In this study, the investigators try to elucidate the biological functions of exosomes in children with adenoid hypertrophy accompanied by OME. Patients with adenoid hypertrophy or otitis media will be separated into three groups: those with adenoid hypertrophy, with otitis media and with adenoid hypertrophy and otitis media both, as well as a healthy control group. Participants in the four groups will have their middle ear effusion, nasopharyngeal secretion, and peripheral blood samples taken, from which exosomes will be separated for further analysis. Adenoidectomy will be conducted in adenoid hypertrophy accompanied by OME and adenoid hypertrophy alone and their adenoid tissue will be collected. Blood will be collected again 3 months after surgery and middle ear and nasopharyngeal examinations will be performed. Exosomes will be isolated for follow-up studies as before surgery. Investigators will also use proteome research, exosome biomarkers, and high-throughput sequencing to examine the pathophysiology of OME, particularly inflammation-related etiology, in order to provide novel ideas for OME diagnosis and treatment.
NCT00547326
Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.
NCT02019888
The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.
NCT04584073
This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
NCT03848026
Studies have focused on the factors that influence tympanostomy tube (TT) extrusion may contribute to the management of OME. In this study the investigators aimed to assess the correlation between the TT extrusion time and viscosity of the middle ear fluid. 33 patients scheduled for TT insertion included in the study. During the paracentesis, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. After the surgery, patients were controlled monthly until the tubes were seen extruded.The analysis of the correlation between tube extrusion time and viscosity was insignificant (p \>0.05).
NCT03978195
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.
NCT03347461
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
NCT02539654
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
NCT02436304
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
NCT02432105
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
NCT00546117
This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.
NCT02950311
This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.
NCT00736112
The questioned proposed by this study is one of treatment: "To what extent does simultaneous BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard academy approach (tube insertions only) to chronic otitis media with effusion; furthermore, are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly prevent ROM after the tubes fall out?" The trial seeks to provide evidence that the treatment for Chronic OME in children should involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and subsequent avoidance of the offending foods in order to significantly decrease ROM. To answer this question, a prospective, randomized controlled trial needs to be conducted. Since a majority of OME patients are from the pediatric population, parental consent must be obtained. Subjects in our study will initially present to the clinic with otitis media symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent otitis media will be obtained. Once the surgical decision for bilateral myringotomy and tympanostomy tubes has been made, parents will be informed about the trial. The standard protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore, data from the control group (Group 1) will be obtained from faculty ENT who follow the academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty members, including the faculty co-investigator who will perform the BMT and obtain a food allergy blood draw at the time of surgery. The study's faculty co-investigator will describe food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study. The incidence of ROM episodes in all trial groups will be recorded.