Clinical Feasibility of a Non-invasive Wearable Acoustic Device for Measuring Air trapping in COPD

This study develops a low-cost, non-invasive, acoustic-based wearable device to continuously monitor and detect lung resonance. The overall objective of this pilot trial is to validate 'Sylvee' algorithm, an Acoustic Resonance Index Analysis (ARIA) system, in remotely monitoring the lung function of patients with COPD, which in turn reduces healthcare costs and improve patients' quality of life.

Study Type/Phase: Observational
Status: Recruiting

This study adopts the use of low-frequency ultrasound to enable a non-invasive, portable, easy-to-use method to measure air trapping for the early diagnosis of COPD and detection of disease exacerbation.

This study requires 1 visit with the study team that lasts approximately 4 hours. Subject will be subjected to the assessments below wearing the Sylvee device.

  • Completing questionnaires
  • Vital signs
  • Lung function tests (Spirometry with Pre and Post Bronchodilator, DLCO and Body Plethysmography
  • Metronome breathing
  • 6-minute walk distance test

Who can participate?

Healthy controls:
No previous history of smoking nor diagnosed chronic lung conditions.

COPD patients:

  • Ages over 40 years old
  • Documented diagnosis of COPD with preserved function of at least 80%
  • History of smoking at least 10 cigarette-pack-years
  • Not pregnant

 

Principal Investigator

Ganesh Krishna, MD

Sponsor

Respira Labs

NCT Number

NCT04450368

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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