The Japanese Home-health Apparatus Industrial Association is an official independent organization comprising ten departments. That concerned with home electronic sphygmomanometers, which has seven participants from different Japanese manufacturers, has already undertaken and is currently involved in various activities related to voluntary standards for performance validation and quality assurance. Because Japanese companies form a large proportion of manufacturers, these activities are important in terms of autonomic regulation. Although many improvements have been made to home electronic sphygmomanometers, some problems still remain unresolved, especially in terms of measurement reliability and easy operation by lay people. Another aspect of the department's work relates to making proposals on major validation standards, such as those of the Association for the Advancement of Medical Instrumentation, the British Hypertension Society and Comité Européen de Normalisation (CEN). Clinical validation should be discussed in order to define a more accurate standard method of measurement using auscultation and more appropriate criteria that are unaffected by primary blood pressure variation.
Obstructive sleep apnea (OSA) places an enormous pressure load on the cardiovascular system by inducing a temporary blood pressure (BP) surge (sleep BP surge (SLBPS)), often resulting in target organ damage and cardiovascular events, such as left ventricular hypertrophy, sudden death, myocardial infarction and stroke. Accurate measurement of SLBPS would be valuable for the risk stratification of OSA patients. We developed a new oxygen-triggered BP monitoring system based on a variable SpO 2 threshold (VT algorithm) to selectively detect severe SLBPS, which are associated with morbidity, and evaluated its performance in comparison with a previous technique based on a fixed SpO 2 threshold (FT algorithm). In 23 OSA patients, the correlation between individual minimum SpO 2 values and SLBPS was not significant when the FT algorithm was used alone (r¼0.400, P¼0.058) but became significant (r¼0.725, Po0.0001) when the VT algorithm was additionally used. In another 13 OSA patients, when the FT algorithm was eliminated from the FT+VT algorithm, the number of BP readings was drastically reduced (36±22.7 vs. 61±55.0 times, P¼0.004) with a similar correlation between minimum SpO 2 and SLBPS. The correlation between the apnea hypopnea index and SLBPS was significant when measured with the present method, but not when assessed with ambulatory BP monitors (ABPM) simulation (r¼0.519, P¼0.001 vs. r¼0.149, P¼0.385). In conclusion, oxygen-triggered BP monitoring with a variable threshold is able to detect severe OSA-related BP surges more specifically and reduce the number of BP readings required during sleep compared with detection using a fixed threshold or the conventional ABPM method.
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