Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-06-30

Brief Summary

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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. Researcher can use Diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.

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Detailed Description

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The research can use low energy laser signal light from Diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states

Conditions

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Middle Ear Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Medical Tool

Diffuse optical spectroscopy imaging ear exam

Diffuse optical spectroscopy imaging

Intervention Type DEVICE

ear exam imaging

Interventions

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Diffuse optical spectroscopy imaging

ear exam imaging

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No