Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04812093

Conditions

Middle Ear Infection

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Interventions

Spectroscopic otoscope measurements

Study Details

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.

Conditions

Middle Ear Infection

Study ID

NCT04812093

Start date

Feb 26, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Medical Tool

Spectroscopic otoscope

Interventions

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 measure

  • Middle Ear Exam [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

John Weidling, PhD

949-824-9613jweidlin@uci.edu

Locations

Children's Hospital of Orange County (CHOC)

Recruiting

Orange, California, United States, 92868

UCI Otolaryngology Clinic

Recruiting

Orange, California, United States, 92868

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 13, 2026

Last verified

Jan, 2026

Keywords

  • Middle Ear Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-13.