Evaluation of middle ear infections using light measurements
Spectroscopic Evaluation of Middle Ear Infection
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 2 sites (Orange, California and 1 other locations) |
| Trial ID | NCT04812093 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals of all ages diagnosed with a middle ear infection who are planning for a surgical procedure.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orange, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.