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Strados Labs has developed the Stradosâ„¢ Respiratory Care Platform, including the RESPâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Device: RESP Biosensor The RESP Biosensor will be placed on all qualitfying subjects for recording of auscultory sound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPâ„¢ Biosensor | Device | For this observational study, the RESPâ„¢ Biosensor will be placed on the patient for periodic recording of auscultory sound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined. | 12 months |
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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
Exclusion Criteria:
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Subjects who are hospitalized for COPD exacerbation with plan for discharge within 48 hoursare, OR are visiting their pulmonologist in the outpatient setting or via telehealth within 14 days of a COPD exacerbation with inpatient stay.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Einstein Philadelphia Hospital | Philadelphia | Pennsylvania | 19141 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |