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ENROLLING BY INVITATION
NCT06544928

Study on Home Obstructive Respiratory Exacerbations

Sponsor: Strados Labs, Inc.

View on ClinicalTrials.gov

Summary

Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health. Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study. We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.

Official title: Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-12-05

Completion Date

2027-03-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DEVICE

RESP™ Biosensor

For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound.

Locations (1)

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, United States