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In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbations | Device | This Study aims to pilot software algorithms based on respiratory features and hemodynamics for predicting exacerbations on a total of 20 participants with COPD. The end-points of this Study includes the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Identifying readmissions using respiratory biomarkers | To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit. | 60-days |
| Measure | Description | Time Frame |
|---|---|---|
| Validate compliance and usability | To validate level of usability using self-assessed questionnaires required to get participants to follow-on | 60-days |
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Inclusion Criteria:
Subject age 18 or older
Receives all primary and specialty care at Institution
Participants will be enrolled at discharge (and not designate hospital or ED)
A history of one of the following diagnoses:
a. c. Chronic obstructive pulmonary disease
At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:
a. Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids.
Participants able to provide informed consent.
Participants will be enrolled at discharge (and not designate hospital or ED)
Exclusion Criteria:
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The enrolment goal is 20 participants with at least 2 documented exacerbations in the past 12 months for a period of 8 weeks each. In addition to the baseline visit and Study on-boarding, there will be 2 follow-ups every month. Participants will be enrolled at discharge (and not designate hospital or ED).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gurpreet Singh Singh | Contact | 6590617570 | gurpreet@respiree.com |
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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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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