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Coherent Optical Detection of Middle Ear Disease (OCTII)

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ClinicalTrials.gov Identifier: NCT05353569
Recruitment Status : Not yet recruiting
First Posted : April 29, 2022
Last Update Posted : April 29, 2022
Sponsor:
Collaborators:
University of Illinois at Urbana-Champaign
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Joseph Kerschner, Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media Otitis Media With Effusion Otitis Media Acute Diagnostic Test: OCT Device(s) Not Applicable

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 we will explore three specific aims. The first aim, part A, we 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, we 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, we 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Midtown Health Clinic
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)).

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)).




Primary Outcome Measures :
  1. Midtown Health Center Analysis (Standard-of-Care Diagnosis) [ Time Frame: 5 years ]
    We 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).

  2. Midtown Health Center Analysis (Research Device Diagnosis) [ Time Frame: 5 years ]
    We will look at the percentage of patients that receive the decision for antibiotic prescriptions after the addition of a research-only OCT device.

  3. Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis) [ Time Frame: 5 years ]
    We 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).

  4. Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis) [ Time Frame: 5 years ]
    We will look at the percentage of patients that receive the decision for surgical intervention after the addition of research-only OCT devices.



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parental complaint of ear infection or ear pain (Midtown Health Center) 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
  • For children being referred for evaluation of otitis media with effusion, effusion present for less than 8 weeks.
  • Current ear tubes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05353569


Contacts
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Contact: Katherine Peterson, MPH 414-805-5356 kapeterson@mcw.edu

Sponsors and Collaborators
Medical College of Wisconsin
University of Illinois at Urbana-Champaign
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Joseph Kerschner, MD Medical College of Wisconsin
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Responsible Party: Joseph Kerschner, Dean and Executive Vice President, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT05353569    
Other Study ID Numbers: 1845494
1R01DC019412-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases