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

Inclusion Criteria3

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

Exclusion Criteria4

  • 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.

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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