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Spectroscopic Evaluation of Middle Ear Infection

Spectroscopic Evaluation of Middle Ear Infection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04812093
Enrollment
150
Registered
2021-03-23
Start date
2021-02-26
Completion date
2028-12-31
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle Ear Infection

Keywords

Middle Ear Infection

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. 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

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.

Sponsors

University of California, Irvine
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Middle Ear Exam5 minutesThe level of light scattering and absorption as measured will be the predictor and presence of fluid behind the ear drum as determined by the surgeon during ear tube placement procedure will be our outcome variable.

Countries

United States

Contacts

CONTACTJohn Weidling, PhD
jweidlin@uci.edu949-824-9613
PRINCIPAL_INVESTIGATORElliot Botvinick

University of Calfornia Irvine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026