BackgroundThere is a pressing need to reduce the hospitalization rate of heart failure patients to limit rising health care costs and improve outcomes. Tracking physiologic changes to detect early deterioration in the home has the potential to reduce hospitalization rates through early intervention. However, classical approaches to in-home monitoring have had limited success, with patient adherence cited as a major barrier. This work presents a toilet seat–based cardiovascular monitoring system that has the potential to address low patient adherence as it does not require any change in habit or behavior.ObjectiveThe objective of this work was to demonstrate that a toilet seat–based cardiovascular monitoring system with an integrated electrocardiogram, ballistocardiogram, and photoplethysmogram is capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation.MethodsThe toilet seat–based estimates of blood pressure and peripheral blood oxygenation were compared to a hospital-grade vital signs monitor for 18 subjects over an 8-week period. The estimated stroke volume was validated on 38 normative subjects and 111 subjects undergoing a standard echocardiogram at a hospital clinic for any underlying condition, including heart failure.ResultsClinical grade accuracy was achieved for all of the seat measurements when compared to their respective gold standards. The accuracy of diastolic blood pressure and systolic blood pressure is 1.2 (SD 6.0) mm Hg (N=112) and –2.7 (SD 6.6) mm Hg (N=89), respectively. Stroke volume has an accuracy of –2.5 (SD 15.5) mL (N=149) compared to an echocardiogram gold standard. Peripheral blood oxygenation had an RMS error of 2.3% (N=91).ConclusionsA toilet seat–based cardiovascular monitoring system has been successfully demonstrated with blood pressure, stroke volume, and blood oxygenation accuracy consistent with gold standard measures. This system will be uniquely positioned to capture trend data in the home that has been previously unattainable. Demonstration of the clinical benefit of the technology requires additional algorithm development and future clinical trials, including those targeting a reduction in heart failure hospitalizations.

BackgroundWearable and connected in-home medical devices are typically utilized in uncontrolled environments and often measure physiologic signals at suboptimal locations. Motion artifacts and reduced signal-to-noise ratio, compared with clinical grade equipment, results in a highly variable signal quality that can change significantly from moment to moment. The use of signal quality classification algorithms and robust feature delineation algorithms designed to achieve high accuracy on poor quality physiologic signals can prove beneficial in addressing concerns associated with measurement accuracy, confidence, and clinical validity.ObjectiveThe objective of this study was to demonstrate the successful extraction of clinical grade measures using a custom signal quality classification algorithm for the rejection of poor-quality regions and a robust QRS delineation algorithm from a nonstandard electrocardiogram (ECG) integrated into a toilet seat; a device plagued by many of the same challenges as wearable technologies and other Internet of Things–based medical devices.MethodsThe present algorithms were validated using a study of 25 normative subjects and 29 heart failure (HF) subjects. Measurements captured from a toilet seat-based buttocks electrocardiogram were compared with a simultaneously captured 12-lead clinical grade ECG. The ECG lead with the highest morphological correlation to buttocks electrocardiogram was used to determine the accuracy of the heart rate (HR), heart rate variability (HRV), which used the standard deviation of the normal-to-normal (SDNN) intervals between sinus beats, QRS duration, and the corrected QT interval (QTc). These algorithms were benchmarked using the MIT-BIH Arrhythmia Database (MITDB) and European ST-T Database (EDB), which are standardized databases commonly used to test QRS detection algorithms.ResultsClinical grade accuracy was achieved for all buttocks electrocardiogram measures compared with standard Lead II. For the normative cohort, the mean was −0.0 (SD 0.3) bpm (N=141 recordings) for HR accuracy and −1.0 (SD 3.4) ms for HRV (N=135). The QRS duration and the QTc interval had an accuracy of −0.5 (SD 6.6) ms (N=85) and 14.5 (SD 11.1) ms (N=85), respectively. In the HF cohort, the accuracy for HR, HRV, QRS duration, and QTc interval was 0.0 (SD 0.3) bpm (N=109), −6.6 (SD 13.2) ms (N=99), 2.9 (SD 11.5) ms (N=59), and 11.2 (SD 19.1) ms (N=58), respectively. When tested on MITDB and EDB, the algorithms presented herein had an overall sensitivity and positive predictive value of over 99.82% (N=900,059 total beats), which is comparable to best in-class algorithms tuned specifically for use with these databases.ConclusionsThe present algorithmic approach to data analysis of noisy physiologic data was successfully demonstrated using a toilet seat-based ECG remote monitoring system. This approach to the analysis of physiologic data captured from wearable and connected devices has future potential to enable new types of monitoring devices, providing new insights through daily, i...

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BACKGROUND There is a pressing need to reduce the hospitalization rate of heart failure patients to limit rising health care costs and improve outcomes. Tracking physiologic changes to detect early deterioration in the home has the potential to reduce hospitalization rates through early intervention. However, classical approaches to in-home monitoring have had limited success, with patient adherence cited as a major barrier. This work presents a toilet seat–based cardiovascular monitoring system that has the potential to address low patient adherence as it does not require any change in habit or behavior. OBJECTIVE The objective of this work was to demonstrate that a toilet seat–based cardiovascular monitoring system with an integrated electrocardiogram, ballistocardiogram, and photoplethysmogram is capable of clinical-grade measurements of systolic and diastolic blood pressure, stroke volume, and peripheral blood oxygenation. METHODS The toilet seat–based estimates of blood pressure and peripheral blood oxygenation were compared to a hospital-grade vital signs monitor for 18 subjects over an 8-week period. The estimated stroke volume was validated on 38 normative subjects and 111 subjects undergoing a standard echocardiogram at a hospital clinic for any underlying condition, including heart failure. RESULTS Clinical grade accuracy was achieved for all of the seat measurements when compared to their respective gold standards. The accuracy of diastolic blood pressure and systolic blood pressure is 1.2 (SD 6.0) mm Hg (N=112) and –2.7 (SD 6.6) mm Hg (N=89), respectively. Stroke volume has an accuracy of –2.5 (SD 15.5) mL (N=149) compared to an echocardiogram gold standard. Peripheral blood oxygenation had an RMS error of 2.3% (N=91). CONCLUSIONS A toilet seat–based cardiovascular monitoring system has been successfully demonstrated with blood pressure, stroke volume, and blood oxygenation accuracy consistent with gold standard measures. This system will be uniquely positioned to capture trend data in the home that has been previously unattainable. Demonstration of the clinical benefit of the technology requires additional algorithm development and future clinical trials, including those targeting a reduction in heart failure hospitalizations.