Otitis Media Effusion

The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement. The main question it aims to answer is: Can a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media? Researchers will compare children who receive the standardized OMT protocol with children who receive a placebo/control manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery. Participants will: * Attend 4 weekly study visits before their final ENT surgical decision. * Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization. * Complete study-related assessments and questionnaires related to ear symptoms and quality of life. * Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will: * Have a video of their ear taken by their parent or their guardian * Have a video of their ear taken by a Primary Care Physician (PCP) * Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT). The videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.

Acute otitis media (AOM), or middle ear infection, is one of the most common childhood infections and a leading cause of antibiotic prescribing in primary care. Diagnosing AOM can be challenging, as ear symptoms and eardrum appearances often overlap with mild or transient conditions. This uncertainty may lead to both unnecessary antibiotic use and missed cases requiring treatment, affecting patient safety and contributing to antibiotic resistance. This study evaluates two digital tools designed to support more accurate diagnosis and treatment decisions in primary care: 1. AOM Dx \[diagnosis\] Trainer (Otitspelet) - a gamified digital training program for physicians that provides interactive exercises using eardrum images and patient cases, with direct feedback to improve diagnostic accuracy and adherence to guidelines. 2. AI-based diagnostic support - a system that analyses tympanic membrane images, with and without symptom and tympanometry data, to evaluate its potential for future diagnostic use. The trial is coordinated by the Västra Götaland Region (VGR) in collaboration with Umeå University and conducted across four Swedish regions: Västra Götaland, Västerbotten, Östergötland, and Skåne. VGR leads the evaluation of the AOM Dx Trainer intervention, while Umeå University leads the AI development and retrospective diagnostic analyses. The study is carried out as a multicentre, cluster-randomised controlled trial in primary care, where participating primary care centres are randomised to either the training intervention or standard care. Physicians are the research participants under evaluation. At intervention centres, physicians complete training with the AOM Diagnosis (Dx) Trainer before study start; at control centres, no training is provided. Each participating centre then conducts an 8-week observation period, during which physicians diagnose and manage patients with new-onset ear symptoms. Patients are included only to allow evaluation of physicians' diagnostic and treatment decisions and to provide data for AI analysis. Estimated patient enrollment is \~200. Depending on centre size and recruitment success, up to 20 primary care centres across four Swedish regions - Västra Götaland, Västerbotten, Östergötland, and Skåne - will participate. After each consultation, research nurses collect tympanic membrane images and tympanometry data from patients who have given informed consent. These data are used for expert panel reference diagnoses and retrospective AI analysis; no information is shared with treating physicians. The primary outcome is diagnostic accuracy of tympanic membrane assessment by physicians trained with the AOM Dx Trainer compared with untrained physicians, using expert consensus as the reference standard. Secondary outcomes include adherence to treatment guidelines and antibiotic prescribing rates. The AI system's diagnostic performance will also be benchmarked against the expert panel and physician groups. By combining educational and technological innovation, this study aims to enhance diagnostic precision, improve guideline adherence, and reduce unnecessary antibiotic use in primary care-strengthening antimicrobial stewardship and providing a scalable model for future infection management.

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.