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 type | Observational |
|---|---|
| Ages | Any age to 21 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 2 sites (Orange, California and 1 other locations) |
| Status | Recruiting |
| Started | February 26, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT04812093 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.