Clinical trial Recruiting at 2 sites Observational Ages Any age to 21

Evaluation of middle ear infections using light measurements

Official title: Spectroscopic Evaluation of Middle Ear Infection

Run by University of California, Irvine · NCT04812093 · Data updated 2026-11-12

This study is testing a new way to diagnose middle ear infections in children by shining special LED lights into the ear to see if there's any fluid or inflammation.

Quick facts

Study typeObservational
AgesAny age to 21 Years
SexAll
Enrollment150 (estimated)
SponsorUniversity of California, Irvine
Academic / other
Locations2 sites (Orange, California and 1 other locations)
StatusRecruiting
StartedFebruary 26, 2021
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedFebruary 13, 2026
Trial IDNCT04812093 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals of all ages diagnosed with a middle ear infection who are planning for a surgical procedure.

Probably not a fit

Patients who are pregnant, cognitively impaired, or do not have a diagnosis of middle ear infection will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on improving the diagnosis of middle ear infections, particularly in children, by utilizing LED-based multi-wavelength light absorption and scattering measurements. Researchers will send low-energy LED light into the ear canal to analyze the optical properties of the eardrum, determining the presence of fluid or inflammation. The results will be processed by a microprocessor to enhance diagnostic accuracy compared to traditional methods that rely on subjective visual assessments.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses of middle ear infections, potentially reducing unnecessary surgeries and improving patient outcomes.

How similar studies have gone: While the use of spectroscopic methods in ear diagnostics is innovative, similar approaches have shown promise in other areas of medical diagnostics, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Children's Hospital of Orange County (CHOC)
    Orange, California, United States
    Recruiting
  • UCI Otolaryngology Clinic
    Orange, California, United States
    Recruiting

Study contacts

  • Principal investigator: Elliot Botvinick — University of Calfornia Irvine
  • Study coordinator: John Weidling, PhD
  • Email: jweidlin@uci.edu
  • Phone: 949-824-9613

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.