JOURNAL ARTICLE
VALIDATION STUDIES
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Pulse Arrival Time Based Cuff-Less and 24-H Wearable Blood Pressure Monitoring and its Diagnostic Value in Hypertension.

Ambulatory blood pressure monitoring (ABPM) has become an essential tool in the diagnosis and management of hypertension. Current standard ABPM devices use an oscillometric cuff-based method which can cause physical discomfort to the patients with repeated inflations and deflations, especially during nighttime leading to sleep disturbance. The ability to measure ambulatory BP accurately and comfortably without a cuff would be attractive. This study validated the accuracy of a cuff-less approach for ABPM using pulse arrival time (PAT) measurements on both healthy and hypertensive subjects for potential use in hypertensive management, which is the first of its kind. The wearable cuff-less device was evaluated against a standard cuff-based device on 24 subjects of which 15 have known hypertension. BP measurements were taken from each subject over a 24-h period by the cuff-less and cuff-based devices every 15 to 30 minutes during daily activities. Mean BP of each subject during daytime, nighttime and over 24-h were calculated. Agreement between mean nighttime systolic BP (SBP) and diastolic (DBP) measured by the two devices evaluated using Bland-Altman plot were -1.4 ± 6.6 and 0.4 ± 6.7 mmHg, respectively. Receiver operator characteristics (ROC) statistics was used to assess the diagnostic accuracy of the cuff-less approach in the detection of BP above the hypertension threshold during nighttime (>120/70 mmHg). The area under ROC curves were 0.975/0.79 for nighttime. The results suggest that PAT-based approach is accurate and promising for ABPM without the issue of sleep disturbances associated with cuff-based devices.

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