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Recruiting NCT05353569

Coherent Optical Detection of Middle Ear Disease

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Plain-language summary for patients

Trial Parameters

Condition Otitis Media
Sponsor Medical College of Wisconsin
Study Type INTERVENTIONAL
Phase N/A
Enrollment 235
Sex ALL
Min Age 12 Months
Max Age 6 Years
Start Date 2022-05-24
Completion 2027-04
Interventions
OCT Device(s)

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Brief Summary

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 otoscopy will be compared to those made with the addition of OCT.

Eligibility Criteria

Inclusion Criteria: * Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic) * Speak English Exclusion Criteria: * Children with craniofacial abnormalities * Children with diagnosed immunologic abnormalities * Children with congenital syndromic conditions * Current open and functioning ear tubes

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