RecruitingNot ApplicableNCT05353569

Coherent Optical Detection of Middle Ear Disease

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


Sponsor

Medical College of Wisconsin

Enrollment

235 participants

Start Date

May 24, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 MonthsMax Age: 6 Years

Inclusion Criteria2

  • 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 Criteria4

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

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Interventions

DIAGNOSTIC_TESTOCT Device(s)

Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).


Locations(2)

Children's Wisconsin ENT Clinic

Wauwatosa, Wisconsin, United States

Children's Wisconsin Urgent Care Clinics

Wauwatosa, Wisconsin, United States

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NCT05353569


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