Digital Otoscopy for Ear Infections
(Wispr 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool for diagnosing ear infections in children, using digital otoscopes instead of traditional ones. The goal is to determine if these digital devices can improve the frequency and accuracy of diagnosing and treating ear infections with antibiotics. Four pediatric clinics in Massachusetts are involved, with two using the new digital otoscopes and two continuing with the standard ones. Clinics not already using digital otoscopy and having 4-9 exam rooms are eligible to participate. As an unphased trial, this study provides a unique opportunity to advance pediatric care by evaluating innovative diagnostic tools.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on the use of digital otoscopes for diagnosing ear infections.
What prior data suggests that digital otoscopy is safe for diagnosing ear infections?
Research has shown that digital otoscopes, such as the Wispr Digital Otoscope, are safe and well-liked for diagnosing ear infections. Studies have found that both patients and doctors feel comfortable using these devices. Doctors report satisfaction with their ease of use and the clear images they provide. No major negative effects have been reported from using digital otoscopes, making them a dependable tool for diagnosing ear infections without added risk.12345
Why are researchers excited about this trial?
Researchers are excited about digital otoscopy for diagnosing ear infections because it brings a modern twist to a common medical procedure. Unlike traditional otoscopes, the digital otoscope captures high-quality images of the ear, potentially enabling more accurate diagnoses. This device could make it easier for healthcare providers to share images with specialists, improving consultations and patient care. With the possibility of better diagnosis and treatment planning, digital otoscopy represents a significant step forward in managing ear infections.
What evidence suggests that digital otoscopy is effective for diagnosing ear infections?
Research shows that digital otoscopes, such as the Wispr, help doctors diagnose ear infections more accurately. In this trial, participants in the experimental arm will use the Wispr Digital Otoscope, which has lowered unnecessary antibiotic prescriptions for common ear infections like acute otitis media (AOM). Other research supports that digital otoscopes enable healthcare providers to identify ear problems more accurately. These devices are safe and popular among healthcare professionals. Overall, digital otoscopes offer a promising tool for better diagnosing and managing ear infections in children.25678
Who Is on the Research Team?
Louis Vernacchio, MD, MSc
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric primary care practices in Massachusetts. It focuses on young children with ear infections, specifically acute otitis media. The goal is to see if using digital otoscopes improves diagnosis and treatment compared to standard methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Training
Clinicians in intervention practices attend training sessions on the use of digital otoscopy
Data Collection
Data collection period to analyze the difference in OM Treatment Index (OMTI) and other secondary outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digital Otoscope
Trial Overview
The study tests the effectiveness of digital otoscopes (Wispr Digital Otoscope) against traditional ones in diagnosing and treating ear infections. Practices are split into two groups: one uses the new device after training, while the other continues with standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
No intervention - standard otoscopy to be used
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Citations
Study Details | NCT07328555 | Digital Otoscopy Versus ...
Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of ...
Wispr Featured in International Journal of Pediatric ...
The study's results demonstrated that the Wispr Digital Otoscope can significantly reduce unnecessary antibiotic prescriptions for acute otitis media (AOM) ...
Evaluating the efficacy of digital otoscopes in rural pediatric ...
Conclusion: Our findings provide strong evidence that digital video otoscope can enhance the diagnostic accuracy of GPs in detecting ear diseases, especially in ...
Health technology assessment of video otoscopy for the ...
This HTA concluded that video otoscope is clinically effective, cost-effective, and operationally feasible in Indian primary health settings, for diagnosing ...
Digital Otoscope vs Education for Ear Infections
Research has shown that using a digital otoscope to diagnose ear infections is safe and well-received. One study found that digital otoscopes, such as the Wispr ...
Digital Otoscope Versus Education and Feedback for Otitis ...
Randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections.
WiscMed: Wispr® Digital Otoscope. The Otoscope. Reinvented.
The digital otoscope comes with a built-in processor that expedites the taking of photos and downloading.
Computer-assisted diagnosis of ear pathologies ...
Computer-assisted diagnosis of ear pathologies by combining digital otoscopy with complementary data using machine learning.
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