Digital Otoscopy for Ear Infections

(Wispr 2 Trial)

JH
JG
Overseen ByJane Gould, MPH
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

LV

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

My practice has 4-9 exam rooms and agrees to use digital otoscopy for 6 months.
Not currently using digital otoscopy
Not involved in the network's previous digital otoscopy study

Exclusion Criteria

Currently using any digital otoscope

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Training

Clinicians in intervention practices attend training sessions on the use of digital otoscopy

2 months
1 initial training session, 2 follow-up sessions

Data Collection

Data collection period to analyze the difference in OM Treatment Index (OMTI) and other secondary outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Experimental: Digital OtoscopyExperimental Treatment1 Intervention
Group II: No intervention: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

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) ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40700974/

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.