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Enrolling By Invitation NCT06544928

Study on Home Obstructive Respiratory Exacerbations

Conditions: COPD Exacerbation, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation Acute, COPD

Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: No
Enrollment: 20
Sponsor: Strados Labs, Inc.

Location: Rutgers Robert Wood Johnson Medical School (RWJMS) New Brunswick New Jersey

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.

Eligibility Criteria

Inclusion Criteria: 1\. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06544928). StuddyBuddy aggregates publicly available trial information.