Spectroscopic Evaluation of Middle Ear Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spectroscopic otoscope measurements.
- Who it may be relevant to
- Registry conditions: Middle Ear Infection. Basic parameters: up to 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Device Spectroscopic 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.
Primary outcome measures
- Middle Ear Exam [Time frame: 5 minutes]
Eligibility criteria
Inclusion criteria
- Male/ female at all age- newborn to adult.
- Non- pregnant woman.
- Diagnose of middle ear infection and plan for surgery procedure.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Children's Hospital of Orange County (CHOC) — Orange
- UCI Otolaryngology Clinic — Orange
Identifiers
NCT: NCT04812093 · 20163039 · R43DC018248