Actively Recruiting

Phase Not Applicable
Age: 12Months - 6Years
All Genders
NCT05353569

Coherent Optical Detection of Middle Ear Disease

Led by Medical College of Wisconsin · Updated on 2026-01-21

235

Participants Needed

2

Research Sites

305 weeks

Total Duration

On this page

Sponsors

M

Medical College of Wisconsin

Lead Sponsor

U

University of Illinois at Urbana-Champaign

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Coherent Optical Detection of Middle Ear Disease

Who Can Participate

Age: 12Months - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with parental complaint of ear infection or ear pain seen in urgent care clinics
  • Children referred for evaluation of otitis media with effusion at ENT clinic
  • Children who speak English
  • Children aged 1 month to 6 years
Not Eligible

You will not qualify if you...

  • Children with craniofacial abnormalities
  • Children with diagnosed immunologic abnormalities
  • Children with congenital syndromic conditions
  • Children with current open and functioning ear tubes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Children's Wisconsin ENT Clinic

Wauwatosa, Wisconsin, United States, 53226

Actively Recruiting

2

Children's Wisconsin Urgent Care Clinics

Wauwatosa, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

R

Roxanne Link, APNP

CONTACT

C

Christy Erbe

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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