Ear Infection (Otitis)

Researchers are developing an artificial intelligence AI system to identify key anatomical landmarks during otolaryngological surgeries, such as mastoidectomy and other procedures involving the temporal bone. The goal is to enable real-time tracking of critical structures like the incus and lateral semicircular canal to help surgeons avoid damaging important areas during operations. This observational study focuses on improving surgical safety and precision by using AI technology. The AI system uses annotated data points from surgical videos to recognize and segment the incus, lateral semicircular canal, facial nerve, and facial nerve recess based on their positions relative to surrounding tissues. The model enhances images with contrast adjustment and localized magnification, then classifies and locates these structures continuously during surgery. It also applies statistical analysis to predict the facial recesss location to provide useful guidance for surgeons and improves accuracy through ongoing training. Participants undergoing otolaryngological surgeries with microscope exposure of the temporal bone will have their surgeries recorded and analyzed. The study collects high-resolution temporal bone CT scans and surgical video data to assess the AI models accuracy. Researchers will monitor relevant indicators of the AI models performance throughout the study period, as well as during the week from hospital admission to discharge. This study will help evaluate how well AI can assist in identifying important surgical landmarks in real time.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are studying children who experience spontaneous perforation of the tympanic membrane SPTM, a condition where the eardrum tears and causes ear discharge otorrhea. This study aims to understand the bacterial causes of this condition several years after the introduction of the pneumococcal conjugate vaccine PCV13 in 2010. Although the number of acute otitis media AOM cases has decreased since the vaccine, SPTM still occurs in some children and needs further investigation. Children with SPTM are enrolled by pediatricians across France and a sample of middle ear fluid is collected using a cotton-tipped wire swab from the spontaneous ear discharge. This fluid is then transported to specialized microbiology labs for bacterial analysis. The study captures cases where otorrhea appears as the first sign of AOM or after treatment failure or recurrence of AOM symptoms. Participants undergo sample collection during their inclusion visit, and researchers analyze the microbiological profiles of the ear discharge. They also study patient characteristics, clinical features of treatment failure or recurrence, and compare rapid diagnostic test results with laboratory findings. The study involves children aged 3 months to 15 years and continues until October 2028, aiming to improve understanding of ear infections in children.

Researchers are evaluating the effects of balloon sinuplasty treatment compared to a placebo in adults with chronic or recurrent maxillary sinusitis without nasal polyposis. The study aims to determine how effective balloon sinuplasty is in treating maxillary sinusitis and to identify which patients may benefit most. Additionally, the study investigates whether balloon sinuplasty improves Eustachian tube dysfunction. A total of 120 patients are enrolled, divided equally between chronic and recurrent maxillary sinusitis groups, with random assignment to either balloon sinuplasty or placebo treatment. The treatments are performed under local anesthesia in a day surgery setting. In the balloon sinuplasty group, a flexible balloon device is inserted and inflated in the maxillary sinus ostium to dilate it, while the placebo group undergoes a sham procedure mimicking the balloon inflation without the actual treatment. Both groups have the procedure performed on both maxillary sinuses. The study staff and patients are kept unaware of the treatment assignment to maintain blinding. Patients are followed for 12 months after the operation, with evaluations at 3, 6, 9, and 12 months. Participants complete questionnaires including the Sino-Nasal Outcome Test SNOT-22 and the Eustachian Tube Dysfunction Questionnaire ETDQ-7. Clinical assessments include nasal endoscopy, rhinomanometry, tympanometry, tubomanometry, and Cone Beam Computed Tomography CBCT scans before and after treatment. Biopsies of nasal mucosa are taken during the operation and after 12 months. Researchers also track sinus infection episodes, antibiotic use, sick leaves, and symptom severity using visual scales. The studys primary outcomes focus on changes in quality of life and infection frequency, with safety and effectiveness monitored throughout.

Researchers are studying adolescents who are often exposed to tobacco smoke at home and suffer from chronic dysfunction of the Eustachian tube, which can affect ear health and lung functions. The study aims to evaluate whether adding Buteyko Breathing techniques to a smoking hygiene approach can improve these conditions. This is a randomized, interventional study focused on evaluating these breathing and hygiene methods in this specific group of adolescents. The study involves 40 adolescents divided into two groups of 20 each. Both groups will follow a smoking hygiene approach for six months. One group will also practice Buteyko Breathing for 30 minutes daily, six days a week excluding Fridays, over the same six-month period. This breathing technique is applied by the patients themselves at home. Participants will be evaluated before and after the six-month intervention period using questionnaires about Eustachian tube dysfunction and lung function tests such as forced vital capacity and forced expiratory volume. Additional assessments include tympanometry and parent-reported physical and mental health questionnaires. Researchers will monitor changes in lung and ear function to assess the effects of the interventions during the study period.

This research aims to evaluate the safety and performance of the CLiKX device, which is designed to place ear tubes in children and adults. The ear tubes, also known as tympanostomy tubes, are used to treat chronic ear fluid and other conditions where a doctor decides an ear tube is needed. The study focuses on patients aged 6 months and older who require tympanostomy tube insertion for chronic otitis media or similar conditions. Participants will undergo tympanostomy tube placement using the CLiKX device, a handheld automated surgical tool that helps create precise incisions and place the tube accurately. The procedure may be done without anesthesia, with local anesthesia, or if necessary, with mild sedation or general anesthesia. The study will follow patients through baseline, procedure, discharge, and a 30-day follow-up visit to assess device performance, procedural success, and safety. During the study, researchers will monitor how well the procedure is tolerated, tracking pain levels using various scales and evaluating caregiver satisfaction and physician evaluation of the procedure. Safety will be assessed by recording adverse events and medication use up to 30 days after the procedure. Participants will have several study visits including baseline, procedure, post-procedure at discharge, and a follow-up visit one month later.

This research aims to assess whether optical coherence tomography OCT, a technology similar to ultrasound but for the ear, can improve the diagnosis of acute otitis media AOM and otitis media with effusion OME in children. Otitis media is a common ear condition affecting most children and is a leading cause of hearing loss and developmental delays. The study compares diagnoses made using standard otoscopy alone to those made with the addition of OCT to improve accuracy and treatment decisions. Participants will undergo standard-of-care ear examinations including otoscopy, and depending on the study group, additional research-only OCT examinations using specialized devices. Some groups will also receive audiometry and tympanometry testing alongside OCT. The study has different arms assessing diagnosis accuracy in urgent care and ENT clinic settings, with the goal of reducing unnecessary antibiotic use and surgeries through better diagnosis. Researchers will also develop machine learning tools to analyze OCT images and predict middle ear condition outcomes. During the study, children will have ear and hearing evaluations, including otoscopy, audiometry, tympanometry, and OCT imaging. The researchers will track diagnostic accuracy and treatment decisions over five years at clinical sites. The primary outcomes include comparisons of diagnosis results from standard care and OCT-enhanced examinations in both urgent care and ENT clinic settings. This monitoring will help understand how OCT and related tools may improve clinical decisions and reduce complications and costs associated with otitis media.

This research aims to gather detailed information about complicated infections treated by ear, nose, and throat ENT specialists in Ljubljana, Slovenia. It focuses on understanding how complicated infections of the sinuses, ears and temporal bone, neck soft tissues, and larynx are managed. The purpose is to improve treatment outcomes, shorten hospital stays, and develop clear clinical pathways for these diseases in Slovenia by comparing local data with other countries. Participants in this observational study will receive standard care according to established evidence-based clinical guidelines, which may include surgery andor conservative treatments. The study groups consist of patients with complicated infections in different ENT areas, including sinonasal infections, ear or temporal bone infections, neck soft tissue infections, and laryngeal infections. Treatments will be provided as usual without experimental interventions. During the study, researchers will collect data to create a database of patients treated at the University Medical Centre Ljubljana. They will monitor disease-free survival over 12 months and analyze treatment outcomes to provide transparent, ongoing information about managing these infections. Participation involves standard medical care and follow-up to assess recovery and complications, contributing to improved understanding and care quality over time.

This research aims to compare the use of Chitosan-dextran Chitodex gel with the current standard treatment, Gelfoam, as packing materials for the middle ear and external auditory canal during tympanoplasty, ossiculoplasty, and mastoidectomy surgeries. It focuses on patients with tympanic membrane perforations, ossicular chain damage, or chronic otitis media and seeks to identify which material better supports healing and reduces inflammation. The study is a single-blinded, randomized trial assessing surgical success and healing outcomes. During surgery, Chitodex gel is applied in a similar manner to Gelfoam. Approximately 2 mL of gel or foam is placed inside the middle ear to support the graft, followed by about 3 mL applied to the external auditory canal as packing. Both materials come in sterile packaging, and surgeons administer the product during the procedure. The study measures the effectiveness of each product in sealing the graft and preventing air leakage, with images and notes taken for evaluation. Participants will be monitored at several points after surgery 2 and 6 weeks, then 3 and 6 months post-operation. Researchers will check tympanic membrane closure using otoscopic or microscope examination. Additional assessments include hearing improvement, eardrum function, quality of life, surgical ease, operation duration, and the clearance of Chitodex gel from the ear. These evaluations will help determine which packing agent is preferable for middle ear surgery.

Researchers are evaluating the effects of Lactobacillus johnsonii TCI250 probiotics and white pomegranate extract on female vaginal bacteria and inflammation. This trial aims to understand how these supplements may regulate vaginal flora and improve vaginal health in women aged 20 to 45 with certain vaginal bacterial conditions. The study is randomized, double-blind, and includes 150 female participants. Participants will be randomly assigned to one of three groups a placebo group, a group receiving heat-killed Lactobacillus johnsonii TCI250, or a group receiving 500 mg of white pomegranate extract. The intervention lasts 8 weeks, followed by an 8-week observation period. During the study, participants provide information on their diet, lifestyle, and health and undergo biological sample collection for analysis. Throughout the 16-week study, participants will have vaginal epithelial cell samples and blood collected at weeks 0, 8, and 16 to monitor vaginal microbiota changes, inflammation markers, and liver and kidney function. Researchers will assess the vaginal bacterial status using Nugent scores and inflammatory markers like IL-4, IL-10, IL-6, IL-8, MCP-1, TNF-, and IL-1. Data analysis includes statistical comparisons among groups and over time to evaluate the impact of the supplements on vaginal health.