Spectroscopic Evaluation of Middle Ear Infection (Withdrawn)

Withdrawn

• Conditions: Middle Ear Infection
• Interventions: Device: Diffuse optical spectroscopy imaging

• Registration Number: NCT01485471
• Lead Sponsor: University of California, Irvine

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

Detailed Description

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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical Tool	Diffuse optical spectroscopy imaging	Diffuse optical spectroscopy imaging ear exam

Primary Outcome Measures

Name	Time	Method
Middle Ear exam	6 hours	Diffuse optical spectroscopy imaging to evaluate ear drum