Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 6
Healthy Volunteers: f
View:
• 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
Locations
United States
Wisconsin
Children's Wisconsin ENT Clinic
RECRUITING
Wauwatosa
Children's Wisconsin Urgent Care Clinics
RECRUITING
Wauwatosa
Contact Information
Primary
Roxanne Link, APNP
rlink@mcw.edu
414-266-3760
Backup
Christy Erbe
cerbe@mcw.edu
414-955-2670
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2028-04
Participants
Target number of participants: 235
Treatments
Experimental: Children's Wisconsin Urgent Care Clinics
Subjects will receive a standard-of-care otoscopy examination, followed by a research-only examination using an OCT device (PCT).
No_intervention: Children's Wisconsin (Effusion in 0 or 1 ear)
Subjects will only receive a standard-of-care otoscopy examination.
Experimental: Children's Wisconsin (Effusion in 2 ears)
Subjects will receive standard-of-care ear and hearing examinations (otoscopy and audiometry/tympanometry), followed by research-only examinations using two OCT devices (UIUC OCT and PCT).
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), University of Illinois at Urbana-Champaign, National Institutes of Health (NIH)