Coherent Optical Detection of Middle Ear Disease

Otitis Media Clinical Trial

— OCTII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353569
• Other study ID #: 46057
• Secondary ID: 1R01DC019412-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: April 2028

Study information

• Verified date: November 2023
• Source: Medical College of Wisconsin
• Contact: Katherine Peterson, MPH
• Phone: 414-805-5356
• Email: kapeterson[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: April 2028
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Otitis
• Otitis Media
• Otitis Media Acute
• Otitis Media With Effusion

Intervention

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

Locations

Country	Name	City	State
United States	Children's Wisconsin ENT Clinic	Wauwatosa	Wisconsin
United States	Children's Wisconsin Urgent Care Clinics	Wauwatosa	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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