COPD, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation, COPD Exacerbation Acute
Conditions
Keywords
SHORE, SL-RS-SHORE, RESP™ Biosensor, RESP™, Strados Labs
Brief 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.
Interventions
DEVICERESP™ Biosensor
For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound.
Sponsors
Strados Labs, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC\<0.70 or LLN based on post-bronchodilator spirometry * Hospitalized for COPD exacerbation with plan for discharge within 48 hours OR * Visiting pulmonologist post COPD-exacerbation within 14 days of discharge from hospital 3. Tobacco History: Current or Former Smoker * Has smoked at least 100 cigarettes in his/her lifetime 4. Patient can follow study procedures, including instructions for self-placement and operation of biosensor * Patient has experience/owns a smartphone 5. Patient is accessible by telehealth/telephone for duration of the study 6. Patient is able and willing to return to study site for study visits as necessary
Exclusion criteria
1. Patient is unable or unwilling to provide informed consent 2. Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device 3. Patient with end-stage medical condition with expected survival no more than 6 months 4. History of adverse reaction or allergy to adhesives such as TegaDerm®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined. | 12 months |
Countries
United States
Outcome results
None listed