Spectroscopic Evaluation of Middle Ear Infection

NCT ID: NCT04812093

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2028-12-31

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.

Conditions

Middle Ear Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Medical Tool

Spectroscopic otoscope

Spectroscopic otoscope measurements

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Elliot L Botvinick

Professor of Biomedical Engineering and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elliot Botvinick

Role: PRINCIPAL_INVESTIGATOR

University of Calfornia Irvine

Locations

Children's Hospital of Orange County (CHOC)

Orange, California, United States

Site Status: RECRUITING

UCI Otolaryngology Clinic

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John Weidling, PhD

Role: CONTACT

jweidlin@uci.edu

949-824-9613

Facility Contacts

Gurpreet Ahuja, MD

Role: primary

Hamid Djalilian, MD

Role: primary

Other Identifiers

R43DC018248

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20163039

Identifier Type: -

Identifier Source: org_study_id