Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05353569

Conditions

Otitis Media

Otitis Media With Effusion

Otitis Media Acute

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

Interventions

OCT Device(s)

Study Details

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 otoscopy will be compared to those made with the addition of OCT.

Conditions

Otitis Media

Otitis Media With Effusion

Otitis Media Acute

Study ID

NCT05353569

Start date

May 24, 2022

Status verified date

Jan, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

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 congenital syndromic conditions
  • Current open and functioning ear tubes

Study Design

Enrollment

235 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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).

Interventions

OCT Device(s)

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

Primary outcome measure

  • Children's Wisconsin Urgent Care Clinic Analysis (Standard-of-Care Diagnosis) [ Time Frame: 5 years ]
  • Children's Wisconsin Urgent Care Analysis (Research Device Diagnosis) [ Time Frame: 5 years ]
  • Children's Wisconsin ENT Clinic Analysis (Standard-of-Care Diagnosis) [ Time Frame: 5 years ]
  • Children's Wisconsin ENT Clinic Analysis (Research Devices Diagnosis) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Roxanne Link, APNP

414-266-3760rlink@mcw.edu

Christy Erbe

414-955-2670cerbe@mcw.edu

Locations

Children's Wisconsin ENT Clinic

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Katherine Peterson, MPH

4148055356kapeterson@mcw.edu

Children's Wisconsin Urgent Care Clinics

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Katherine Peterson, MPH

4148055356kapeterson@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.