RecruitingNCT04812093

Spectroscopic Evaluation of Middle Ear Infection


Sponsor

University of California, Irvine

Enrollment

150 participants

Start Date

Feb 26, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing spectroscopy — a technique that analyzes how light interacts with tissue — to improve the diagnosis and evaluation of middle ear infections (otitis media). Middle ear infections are extremely common, especially in children, and accurately identifying the type and severity of infection (bacterial vs. viral, acute vs. chronic) can be difficult. Spectroscopy could provide a non-invasive way to quickly gather more information during evaluation. Participants are patients of any age (newborn to adult) who have been diagnosed with a middle ear infection and are already scheduled for a surgical procedure (such as placement of ventilation tubes or tympanoplasty). Spectroscopic measurements are taken during surgery alongside standard clinical assessments. You may be eligible if: - You (or your child) have been diagnosed with a middle ear infection - You are scheduled for a surgical procedure related to the infection - You (or your child's parents) can provide informed consent - You are not pregnant You may NOT be eligible if: - You are pregnant - You have cognitive impairment preventing consent - You are a parent with cognitive impairment who cannot consent on behalf of your child Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpectroscopic otoscope measurements

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.


Locations(2)

Children's Hospital of Orange County (CHOC)

Orange, California, United States

UCI Otolaryngology Clinic

Orange, California, United States

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NCT04812093