Data Collection Using Eko Devices in a Clinical Setting

NCT07270744 | Recruiting

• 1 other identifier: 2025.6
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of the study are to: train and validate binary classifiers for wheeze, coarse crackle, fine crackle, rhonchus, stridor, rales, and cough, as well as determine correspondence between type/location of adventitious lung sound and type of pulmonary condition.

Conditions

Lung Diseases

Keywords

lung sounds; adventitious lung sounds; abnormal lung sounds

Outcome Measures

Primary Outcomes (1)

• Primary Objective: Collection of Lung Sound Recordings to Explore Machine Learning Algorithm for Classifying Adventitious Lung Sounds

  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.

  14-15 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects with complaints of shortness of breath or relevant diagnoses like COPD/heart failure/asthma will be screened for eligibility from the upcoming clinic schedule and then recruited during their clinical appointment. Inpatients may also be identified from the EHR and recruited from inpatient units. In order to achieve the harder-to-fill buckets, it may be necessary to directly target existing registries or patient databases, and/or bring patients in for a research-specific visit. Additionally, patients seen in clinic or in hospital with no known respiratory condition will be recruited and evaluated.

You may qualify if:

• Patients 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, over 18 years old
• Able to provide verbal consent

You may not qualify if:

• Patients unable to have multiple recordings taken on chest and back (e.g. compromised mobility)
• Patients on mechanical ventilation
• Patients unwilling or unable to provide informed consent

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Respiratory Sounds

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)