Coherent Optical Detection of Middle Ear Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-6
SponsorMedical College of Wisconsin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children with craniofacial abnormalities
Children with diagnosed immunologic abnormalities
Children with congenital syndromic conditions
Current open and functioning ear tubes
Trial design
Design model
Parallel
Treatments tested in this trial
OCT Device(s)
Diagnostic testResults from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).
Treatment groups
235 Participants
are divided into 3 treatment groupsGroup A: Children's Wisconsin Urgent Care ClinicsExperimental treatment 1 intervention
Group B: Children's Wisconsin (Effusion in 0 or 1 ear)No intervention 0 interventions
Group C: Children's Wisconsin (Effusion in 2 ears)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis)
The investigators will look at the percentage of patients that receive the decision for antibiotic prescriptions using only a standard-of-care examination (otoscopy) (prior to addition of a research-only OCT device).
Time frame
5 years2
Children's Wisconsin Urgent Care Analysis (Research Device Diagnosis)
The investigators will look at the percentage of patients that receive the decision for antibiotic prescriptions after the addition of a research-only OCT device.
Time frame
5 years3
Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis)
The investigators will look at the percentage of patients that receive the decision for surgical intervention using only standard-of-care examinations (otoscopy, audiometry/tympanometry) (prior to addition of research-only OCT devices).
Time frame
5 years4
Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis)
The investigators will look at the percentage of patients that receive the decision for surgical intervention after the addition of research-only OCT devices.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical College of Wisconsin
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator
National Institutes of Health (NIH)
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov