Spectroscopic Evaluation of Middle Ear Infection

Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Middle Ear Infection Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Orange County (CHOC), Orange, California, United States

About this study

The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male/ female at all age- newborn to adult.
Non- pregnant woman.
Diagnose of middle ear infection and plan for surgery procedure.

Exclusion criteria

Pregnant woman
Incompetent adults (i.e. individuals with cognitive impairment)
No diagnose of middle ear infection and no plan for surgery procedure.
Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Treatment and study plan

Spectroscopic otoscope measurements

Device

Spectroscopic otoscope measurements are taken with the investigational device. Each measurement consists of placing the device in the ear canal and illuminating the ear with multiple light sources in a short period of time. If wax is present in the ear canal, it is removed by the study physician and another measurement is taken.

Primary outcomes

Middle Ear Exam

Time frame: 5 minutes

The level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable.

Study contacts

Contact information is provided by the study sponsor or research team.

John Weidling, PhD

CONTACT

[email protected]

949-824-9613

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start: 2021
Primary completion: 2028
Study completion: 2028
First posted: Mar 23, 2021
Registry last updated: Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting