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Recruiting

NCT Number: NCT07270744

Data Collection Using Eko Devices in a Clinical Setting

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.

Recruiting

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

8443563384

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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

    Time frame: 14-15 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.

Sponsors and collaborators

Lead sponsor

Eko Devices, Inc.

Industry

Registry information

Official study title

Data Collection Using Eko Digital Devices in a Clinical Setting

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 18, 2025

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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