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Spectroscopic Evaluation of Middle Ear Infection

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Enrolling

Conditions

Middle Ear Infection

Treatments

Device: Spectroscopic otoscope measurements

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04812093
R43DC018248 (U.S. NIH Grant/Contract)
20163039

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

150 participants in 1 patient group

Medical Tool
Description:
Spectroscopic otoscope
Treatment:
Device: Spectroscopic otoscope measurements

Trial contacts and locations

2

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Central trial contact

John Weidling, PhD

Data sourced from clinicaltrials.gov

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