There is growing evidence of the clinical significance of daytime masked hypertension (MHT) and blood pressure (BP) variability (BPV). Recently, watch‐type wearable devices for self‐BP measurement have become available. Such devices might be promising tools to identify patients with daytime MHT or large BPV in their real‐life conditions. The present study aimed to validate the accuracy of the Omron HEM‐6410T‐ZM and the Omron HEM‐6410T‐ZL, which are automatic watch‐type wearable devices for self‐BP measurement, according to the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060‐2:2013 guideline. Watches were held with the wrist at heart level. The mean differences between reference BPs and HEM‐6410T‐ZM readings were −0.9 ± 7.6/‐1.1 ± 6.1 mm Hg for systolic BP (SBP)/diastolic BP (DBP) for criterion 1, and −0.9 ± 6.8/‐1.1 ± 5.5 mm Hg for SBP/DBP for criterion 2. The mean differences between reference BPs and HEM‐6410T‐ZL readings were 2.4 ± 7.3/0.7 ± 7.0 mm Hg for SBP/DBP for criterion 1, and 2.4 ± 6.5/0.7 ± 6.5 mm Hg for SBP/DBP for criterion 2. The Omron HEM‐6410T‐ZM and the Omron HEM‐6410T‐ZL both fulfilled both validation criteria 1 and 2 of the ANSI/AAMI/ISO 81060‐2:2013 guidelines.
Obstructive sleep apneas syndrome (OSAS) is associated with nocturnal hypertension with higher sleep blood pressure (BP) and its variability, both of which increase cardiovascular risk. In this crossover design study, the effect of nighttime single-dose administration of vasodilating (nifedipine 40 mg) vs sympatholytic (carvedilol 20 mg) antihypertensive agents on sleep BP in 11 hypertensive OSAS patients was evaluated. The authors recently developed a trigger sleep BP monitor with an oxygen-triggered function that initiates BP measurement when oxygen desaturation falls. The BP-lowering effects of nifedipine on the mean (P<.05) and minimum sleep systolic BPs (SBPs) (P<.01) were stronger than those of carvedilol. Sleep SBP surge (difference between the hypoxiapeak SBP measured by oxygen-triggered function and SBPs within 30 minutes before and after the peak SBP) was only significantly reduced by carvedilol (P<.05). The nighttime dosing of both vasodilating and sympatholytic antihypertensive drugs is effective to reduce sleep BP but with different BP-lowering profiles. J Clin Hypertens (Greenwich). 2014;16:459-466. ª2014 Wiley Periodicals, Inc.Obstructive sleep apnea syndrome (OSAS) is the most frequent cause of secondary hypertension and resistant hypertension, and it is also a risk factor for cardiovascular events, particularly those that occur during sleep.1-5 Population-based and clinical studies have demonstrated that sleep blood pressure (BP) and sleep BP variability are more important for predicting cardiovascular events than awake BP and awake BP variability. 6,7 Patients with hypertensive OSAS are likely to exhibit a nondipper/riser pattern of nocturnal hypertension, often with increased sleep BP variability. Ambulatory BP monitoring (ABPM) has historically been the gold standard for measuring BP during sleep. However, self-measured home BP monitoring can also be used to evaluate sleep BP, with results that are comparable to those of ABPM. 8 The drawback of both monitoring methods is that they use fixed-interval measurement, and thus cannot specifically detect OSAS-related BP variability. 9 Recently, we developed a trigger sleep BP monitoring (TSP) method, which is based on the automated fixed-interval measurement function with an additional oxygen-triggered function that initiates BP measurement when oxygen desaturation falls below a set variable threshold continuously monitored by pulseoximetry.2,10,11 A previous study of noninvasive continuous BP monitoring using a Finapres device (Amsterdam, Netherland) demonstrated a sleep BP surge just after each episode of sleep apnea BP in patients with OSAS.9 TSP is more convenient than Finapres for the clinical assessment of different sleep BP profiles, including mean sleep BP, hypoxia-related peak sleep BP, basal (minimum) sleep BP, and sleep BP surge in patients with OSAS. Neither previous home BP monitoring nor ABPM could detect the peak sleep BP or the sleep BP surge, both of which have been specifically related to hypoxia caused by individual sleep apnea ep...
This study aimed to validate the accuracy of the Omron HEM‐9601T, an automatic wrist‐type device for self‐blood pressure (BP) measurement with a timer function for automatic measurement of nocturnal BP, in the sitting position according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060‐2:2013 guidelines, and to assess its performance in the supine position by applying the same protocol as conducted in the sitting position. The mean differences between the reference BPs and HEM‐9601T readings were 1.2 ± 6.9/1.1 ± 5.5 mmHg, 2.2 ± 6.5/1.8 ± 5.7 mmHg, 0.1 ± 6.6/1.5 ± 6.2 mmHg, and −0.8 ± 7.2/0.5 ± 6.4 mmHg for systolic BP/diastolic BP for criterion 1 in the sitting position, supine with sideways palm position, supine with upward palm position, and supine with downward palm position, respectively. In addition, the mean differences and their standard deviations for systolic BP and diastolic BP calculated according to criterion 2 in the ANSI/AAMI/ISO 81060‐2:2013 guidelines were acceptable in all four positions. In conclusion, the Omron HEM‐9601T fulfilled the validation criteria of the ANSI/AAMI/ISO81060‐2:2013 guidelines when used in the sitting position with the wrist at heart level, and its accuracy in the supine position was acceptable and roughly equivalent to that in the sitting position. The wrist‐type home BP monitor could be a more suitable tool for repeated nocturnal BP measurements at home than upper‐arm devices, and could improve the reliability of diagnosis and management of nocturnal hypertension.
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