Spectroscopic Evaluation of Middle Ear Infection

Middle Ear Infection Clinical Trial

Official title:

Spectroscopic Evaluation of Middle Ear Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812093
• Other study ID #: 20163039
• Secondary ID: R43DC018248
• Status: Recruiting
• Start date: February 26, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: John Weidling, PhD
• Phone: 949-824-9613
• Email: jweidlin[@]uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Middle Ear Infection
• Otitis
• Otitis Media

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Orange County (CHOC)	Orange	California
United States	UCI Otolaryngology Clinic	Orange	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle Ear Exam	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.	5 minutes