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Otitis Media With Effusion clinical trials

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NCT ID: NCT06316635 Recruiting - Clinical trials for Otitis Media With Effusion

Microplastics in Otitis Media With Effusion Material

Start date: March 20, 2024
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT06256081 Completed - Clinical trials for Hearing Loss, Conductive

Testing a New App for Children With Glue Ear

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

To assess whether children with glue ear ( and some normal hearing controls) and their families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing screening section on the app is comparable to the hearing test data obtained from formal audiology hearing tests.

NCT ID: NCT06191562 Recruiting - Clinical trials for Recurrent Acute Otitis Media

Posterior vs. Anterior Tympanostomy Tube Placement

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location. For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems. Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.

NCT ID: NCT06100159 Completed - Quality of Life Clinical Trials

Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion

Start date: January 20, 2017
Phase: N/A
Study type: Interventional

The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are: - Does tympanic tube insertion have an effect on sleep quality in children with chronic OME? - Does tympanic tube insertion improve the quality of life for the children with chronic OME and their caregivers? Participants will have their movements during sleep and number of awakenings measured by an accelerometer placed on their wrist for 7 nights before and after tympanic tube insertion. Their caregivers will answer questionnaires regarding quality of life on behalf of the child. Researchers will compare with a control group of children who also is diagnosed with chronic OME. They will also have their sleep monitored for 7 nights and their caregivers will complete quality of life questionnaires, but the will not receive a tympanic tube. However the control group will be reassessed a month after baseline, and if they still qualify for tympanic tube insertion they will undergo the same routine as the intervention group.

NCT ID: NCT05915078 Recruiting - Otitis Media Clinical Trials

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

Start date: June 15, 2023
Phase:
Study type: Observational [Patient Registry]

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation. The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).

NCT ID: NCT05545345 Not yet recruiting - Clinical trials for Otitis Media With Effusion in Children

Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

Start date: September 2022
Phase: N/A
Study type: Interventional

This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.

NCT ID: NCT05535634 Recruiting - Hearing Loss Clinical Trials

Sound Ear Check (SEC) in Hearing Diagnostics in Young Children

Start date: August 31, 2022
Phase:
Study type: Observational

Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.

NCT ID: NCT05449184 Recruiting - Clinical trials for Otitis Media With Effusion After Nasopharyngeal Carcinoma

A Prospective, Randomized, Controlled Clinical Study of BET Combined With Tympanostomy Tube Insertion in the Treatment of Intractable OME After Radiotherapy for NPC

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05402267 Not yet recruiting - Clinical trials for Otitis Media With Effusion

The Effects of Exosomes in Otitis Media With Effusion

Start date: September 1, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05353569 Recruiting - Otitis Media Clinical Trials

Coherent Optical Detection of Middle Ear Disease

OCTII
Start date: May 24, 2022
Phase: N/A
Study type: Interventional

The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely pneumatic otoscopy (PO) will be compared to those made with the addition of OCT.