Validating and AI Software for Assessment of Children With Ear Concerns

Glimpse Diagnostics, Inc.

Status: Not yet enrolling

Conditions: Otitis Media; Otitis Media Effusion; Otalgia

Study type: Observational

Funder types: Industry; Other; NIH

Identifiers

NCT07243093

Glimpse-01

1R44EB036883-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will:

• Have a video of their ear taken by their parent or their guardian
• Have a video of their ear taken by a Primary Care Physician (PCP)
• Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT).

The videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.

Full description

Ear complaints, including earache (otalgia), are the most common reasons children seek healthcare and routinely bring children into the office of a pediatrician or urgent care setting. This study will assess children who present with signs and symptoms of otitis media to the primary care office or urgent care. Participants will receive their standard of care from their treating physician, with study assessments including videos of their ears taken by their parent or guardian and the treating physician. Once this is complete, participants will see an ENT for an assessment of their eardrum. The ENT assessment will occur within 24 hours of the PCP visit and will not be used to inform patient treatment.

Enrollment: 658 estimated patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 6 months to 6 years
• Presenting to a pediatrician's office or urgent care with signs and symptoms of otitis media, including tugging at ears, ear pain, crying at night, refusing to lie flat, sleeping poorly, having a fever, having decreased appetite, and/or concern for hearing loss, regardless of previous diagnosis of AOM or OME.

Exclusion criteria

• History of craniofacial abnormality
• PE tubes currently in place
• Current otorrhea
• Caretaker not having use of both hands and arms