Coherent Optical Detection of Middle Ear Disease (OCTII)

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

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 pneumatic otoscopy (PO) will be compared to those made with the addition of OCT.

Study Overview

• Status: Recruiting
• Conditions: Otitis Media; Otitis Media With Effusion; Otitis Media Acute
• Intervention / Treatment: Diagnostic test: OCT Device(s)

Detailed Description

Otitis media (OM) is the most common diagnosis in pediatric patients seen for illness in the United States, affects 90% of all children, and is the most common indication for antimicrobial therapy and surgery in young children. Despite many attempts to improve diagnosis, treatment, and prevention, OM continues its highly prevalent impact on children and substantial ongoing morbidity. OM continues as the most common cause of hearing loss in children and leads to speech, educational and other developmental delays. OM causes life-threatening complications and is expensive, resulting in over $5 billion annually in U.S. health care expenditures. Despite the prevalence and difficulties with OM, diagnostic accuracy to allow appropriate treatment is lacking, leading to misplaced resources in treating OM. This proposal builds on our central hypothesis that enhanced diagnostic tools, specifically, optical coherence tomography (OCT), will yield improved diagnosis and lead to reduced need for antibiotics to treat acute OM, reduced surgical interventions for chronic otitis media, and overall fewer complications and cost associated with this disease. In this proposal, the investigators will explore three specific aims. The first aim, part A, the investigators will perform a comparative assessment of middle ear pathology using pneumatic otoscopy (PO) and OCT in pediatric patients that present to a primary care clinic with complaints of otalgia or OM, with the hypothesis that OCT added to standard PO will improve diagnostic accuracy and reduce overall antibiotic prescriptions. In part B of this aim, a comparative assessment of middle ear pathology using PO along with audiology/tympanometry (TY) and OCT will be performed in pediatric patients that present to the pediatric otolaryngology clinic with a referral for chronic otitis media with effusion (OME), with the hypothesis that OCT added to standard PO and TY will improve diagnostic accuracy and reduce overall need for surgery in patients with OME. In the second aim, using the OCT images captured in the previous aim, the investigators will develop image processing and machine learning algorithms for automated identification of effusions and biofilms in OCT image data to augment OM diagnosis for medical decision making. Finally, using the OCT images captured previously, along with our machine learning algorithms, the investigators will establish OCT B-mode and M-mode image-based features that predict the resolution or persistence of middle ear effusions over time. Collectively, this project will demonstrate how these advances in diagnostic tools and algorithms will improve diagnosis and provide added information for clinical decision making in the management of OM.

• Study Type: Interventional
• Enrollment (Estimated): 235
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Peterson, MPH; Phone Number: 414-805-5356; Email: kapeterson@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Recruiting
      • Children's Wisconsin ENT Clinic
      • Contact: Katherine Peterson, MPH; Phone Number: 414-805-5356; Email: kapeterson@mcw.edu
    • Wauwatosa, Wisconsin, United States, 53226
      • Recruiting
      • Children's Wisconsin Urgent Care Clinics
      • Contact: Katherine Peterson, MPH; Phone Number: 414-805-5356; Email: kapeterson@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 other syndromic conditions
• Current ear tubes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Children's Wisconsin (Effusion in 0 or 1 ear); Subjects will only receive a standard-of-care pneumatic otoscopy examination.
Experimental: Children's Wisconsin (Effusion in 2 ears); Subjects will receive standard-of-care ear and hearing examinations (pneumatic otoscopy and audiology/tympanometry), followed by research-only examinations using two OCT devices (UIUC OCT and PCT).	Diagnostic test: OCT Device(s); Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).
Experimental: Children's Wisconsin Urgent Care Clinics; Subjects will receive a standard-of-care pneumatic otoscopy examination, followed by a research-only examination using an OCT device (PCT).	Diagnostic test: OCT Device(s); Results from standard-of-care examinations will be compared to research-only examination(s) (OCT device(s)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (pneumatic otoscopy, audiology/tympanometry) (prior to addition of research-only OCT devices).	5 years
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.	5 years
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 (pneumatic otoscopy) (prior to addition of a research-only OCT device).	5 years
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.	5 years

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Institutes of Health (NIH); National Institute on Deafness and Other Communication Disorders (NIDCD); University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Joseph Kerschner, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Otitis; Otitis Media; Otitis Media with Effusion; Ear Diseases
• Other Study ID Numbers: 46057; 1R01DC019412-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes