A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- ReThink Medical
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Study Endpoint: Skin Temperature
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Evaluate the performance of the CorBand product when used to monitor patients.
Detailed Description
The goal of the study is to demonstrate the validity and reliability of the CorBand across a suite of six clinical measures by comparing the measurements to similar outputs of FDA cleared devices: * CorBand heart rate and heart rate variability will be compared to an electrocardiogram. * CorBand bioimpedance will be compared to recorded extracted fluid and a bioimpedance measurement device. * CorBand respiration rate will be compared to an respiratory rate sensor. * CorBand skin temperature will be compared to a skin temperature monitoring device. * CorBand activity will be compared to an activity monitor. * CorBand outputs will be compared to the outputs of the CardioMEMS system. Device safety, comfort, and ease-of-use will also be evaluated as part of this study. Adverse events and serious adverse events will be documented throughout the study duration.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Study Endpoint: Skin Temperature
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the skin temperature data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Activity
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the activity (steps/movement) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Heart Rate
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the heart rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Respiration Rate
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the respiration rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Heart Rate Variability
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the heart rate variability data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Bioimpedance (Extracellular fluid differences)
Time Frame: Through study completion, an average of 1 week
To evaluate the accuracy of the bioimpedance (extracellular fluid differences) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)