Spectroscopic Evaluation of Middle Ear Infection

Recruiting

• Conditions: Middle Ear Infection
• Interventions: Device: Spectroscopic otoscope measurements

• Registration Number: NCT04812093
• 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. 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.

Study Timeline

• Study Start: 2021-02-26
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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	Spectroscopic otoscope measurements	Spectroscopic otoscope

Primary Outcome Measures

Name	Time	Method
Middle Ear Exam	5 minutes	The 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.

Trial Locations

Locations (2)

Children's Hospital of Orange County (CHOC); 🇺🇸 Orange, California, United States

UCI Otolaryngology Clinic; 🇺🇸 Orange, California, United States