Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease

What this Trial Is About

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.

Coherent Optical Detection of Middle Ear Disease