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NCT Number: NCT07227376

Data Collection Using Eko Digital Devices in a Clinical Setting

The purpose of this research is to prospectively train and validate an artificial intelligence machine learning (ML) algorithm to detect the presence of adventitious lung sounds in adults. Clinicians will use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings to collect normal and abnormal lung sounds, as part of standard of care clinical practice, which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine any correspondences between the type and/or location of adventitious lung sounds and the type of pulmonary conditions as reported by clinicians.

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Key information

Conditions

Lung Diseases Pathological Conditions, Signs and Symptoms Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemours Children's Health, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eko digital stethoscopes

Device

Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to listen for and record lung sounds.

Primary outcomes

  1. Primary Objective

    Time frame: Through study completion, an average of 8-9 months

    The primary objective of this study is to collect normal and abnormal lung sounds of up to 750 patients per study site, by having clinicians use the Eko CORE and/or Eko CORE 500 device(s) in real clinical settings, as part of standard of care clinical practice which will then be used to explore an ML algorithm for classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine any correspondences between the type and/or location of adventitious lung sounds and the type of pulmonary conditions as reported by clinicians.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Associate

CONTACT

[email protected]

8443563384

Sponsors and collaborators

Lead sponsor

Eko Devices, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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