Recording lung sounds with Eko digital stethoscopes in clinic

Data Collection Using Eko Digital Devices in a Clinical Setting

This project will test an AI that listens to lung sounds recorded with Eko digital stethoscopes to find abnormal sounds in people with or without lung disease.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Sex: All
• Sponsor: Eko Devices, Inc. (Industry-sponsored)
• Locations: 2 sites (Jacksonville, Florida and 1 other locations)
• Trial ID: NCT07227376 on ClinicalTrials.gov

What this trial studies

In routine clinic visits, clinicians will use Eko CORE and/or CORE 500 digital stethoscopes to record normal and abnormal lung sounds from the chest and back. Recorded sounds will be labeled with clinician-reported findings and clinical context and then used to train and validate a machine learning algorithm to classify wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough. The study will include adult and pediatric patients as available and capture recordings during standard-of-care encounters. Patients who cannot tolerate multiple recordings or who are on mechanical ventilation are excluded.

Who should consider this trial

Good fit: People who can tolerate multiple chest and back recordings, including adults and children with suspected or diagnosed lower respiratory conditions and healthy individuals without adventitious sounds, are ideal candidates.

Not a fit: People who are mechanically ventilated or unable to have multiple chest/back recordings would not be eligible and are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the AI could help clinicians detect and classify abnormal lung sounds more quickly and consistently, potentially speeding diagnosis and treatment.

How similar studies have performed: Similar AI approaches to automated lung sound analysis have shown promising early results in research settings, but large-scale clinical validation is still limited.

Eligibility criteria

Inclusion Criteria:

* Suspected or diagnosed lower respiratory condition OR Presence of wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough discovered during routine auscultation
* Normal patients with no adventitious lung sounds
* Adults and pediatric patients (as available)

Exclusion Criteria:

* Unable to have multiple recordings taken on chest and back (e.g. compromised mobility)
* On mechanical ventilation

Where this trial is running

Jacksonville, Florida and 1 other locations

• Nemours Children's Health — Jacksonville, Florida, United States (Recruiting)
• Jefferson Einstein Philadelphia Hospital — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Research Associate

Conditions Lung Diseases; lung sounds; adventitious lung sounds; abnormal lung sounds