Parent-led Digital Ear Imaging to Detect Acute Otitis Media
Official title: Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging
Run by Turku University Hospital · NCT07640568 · Data updated 2026-11-12
Parents use a digital otoscope at home and AI analyzes the images to see if a child has acute otitis media, aiming to reduce unnecessary doctor visits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Months to 47 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Turku University Hospital Government |
| Locations | 2 sites (Vaasa, Pohjanmaa and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07640568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Families in Finland with a child who has had at least one AOM in the past 12 months and who speak fluent Finnish.
✕Probably not a fit
Children without access to reliable home imaging or whose parents cannot complete the imaging protocol may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized pilot study tests whether giving families a digital otoscope and using AI-analyzed images of the eardrum can reduce physician visits for suspected AOM. Participants are Finnish-speaking families with a child who had at least one AOM in the past year. After training, parents perform home imaging, which is reviewed retrospectively by an AI classifier to help guide care decisions. The study also looks at diagnostic accuracy, feasibility, antibiotic use, and healthcare utilization. Lead institutions include Turku University Hospital and Vaasa Central Hospital in Finland.
Why it matters
Potential benefit: If successful, the approach could lower unnecessary doctor visits and antibiotic use while maintaining accurate diagnosis of AOM.
How similar studies have gone: Prior work has shown digital otoscopy with AI can accurately identify AOM, supporting the potential effectiveness of this home-based approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least one episode of AOM within the last 12 months * Family speaks fluent Finnish Exclusion Criteria: * Tympanostomy tubes or perforation of the TM, or scheduled for upcoming tympanostomy * Middle ear fluid at the time of recruitment * Previously diagnosed hearing loss * Immunosuppressive disorder or medication, excluding inhaled corticosteroids * Anatomic defect or anomaly affecting the susceptibility to AOM * Previous otoscopy experience of the participating parent
Where it's running
-
Vaasa Central Hospital
Vaasa, Pohjanmaa, Finland Recruiting -
Turku University Hospital
Turku, Southwest Finland, Finland Not yet recruiting
Study contacts
- Principal investigator: Paula A Tähtinen, MD, PhD — Department of Paediatiatrics and Adolescent Medicine, Turku University Hospital and University of Turku, Finland
- Study coordinator: Simo Nuuttila, MD
- Email: simo.c.nuuttila@utu.fi
- Phone: +358503314426
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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.