Ear Infection (Otitis)

Researchers are evaluating the safety, tolerability, and effectiveness of the gene therapy SENS-501 in children aged 6 to 31 months who have severe to profound hearing loss caused by mutations in the Otoferlin gene. This open-label Phase I/II study focuses on children with pre-lingual hearing loss due to these genetic mutations, aiming to better understand how this treatment works in this young population. The study involves administering SENS-501 directly into one ear using a special injection system. It includes a dose-escalation phase where children receive either a low or high dose, followed by a dose expansion phase where the dose recommended from earlier phases is given. The treatment is given as a single unilateral intracochlear injection, and the administration system's safety, performance, and usability are also evaluated. Participants will be followed for up to 5 years to monitor safety and tolerability and to assess hearing improvement using auditory brainstem response (ABR) and pure tone audiometry (PTA). Additional evaluations include clinical checks of the administration system shortly after treatment. Throughout the study, children will undergo hearing tests and medical assessments to measure outcomes and track any side effects or complications from the treatment and procedure.

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 recess's 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 model's accuracy. Researchers will monitor relevant indicators of the AI model's 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 study's 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 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 and/or 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 find out if using topical otic drops during and after tympanostomy tube placement surgery lowers the chances of tube blockage and ear drainage in children who do not have fluid behind their eardrum at the time of surgery. The study focuses on patients aged 6 months to 10 years undergoing this procedure without middle ear effusion. It compares the effects of using ofloxacin ear drops in one ear versus no drops in the other ear to better understand their impact on post-operative outcomes. Participants will receive three drops of ofloxacin otic solution during and after surgery, three times daily for three days, but only in one ear. The ear receiving the drops will be randomly chosen. The other ear will not receive any treatment, allowing each participant to serve as their own control. This design helps researchers directly compare the treated and untreated ears within the same patient. Throughout the study, participants will be monitored for up to 35 days after surgery. Researchers will check for tube blockage and signs of ear drainage during this period. Follow-up visits will assess these outcomes to determine if the drops affect recovery and tube function. The study is conducted by Boston Children's Hospital and aims to provide evidence about the use of topical drops in patients without middle ear fluid at surgery 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.