Data Collection For Adventitious Lung Sounds Algorithm Using Eko Digital Devices in a Clinical Setting

The purpose of this research is to collect patient lung sounds in order to develop an artificial machine learning algorithm that can potentially tell a doctor if a patient is at risk of certain lung conditions.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Care United Research

Forney, Texas, 75126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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 patients (18 years or older)

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

Lung Sounds Collected from Number of Patients

Time frame: Through study completion, an average of 8 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.

Sponsors and collaborators

Lead sponsor

Eko Devices, Inc.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2027
First posted: Jan 22, 2026
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.

Published trials that share one or more normalized conditions with this study.

Recruiting