ArticleHypertension research : official journal of the Japanese Society of Hypertension2026
Evaluation of Alysis-001 cuffless blood pressure estimation algorithm against the European Society of Hypertension awake/asleep test criteria in hypertensive patients.
Article in Hypertension research : official journal of the Japanese Society of Hypertension, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Accurate ambulatory blood pressure monitoring (ABPM) is essential for cardiovascular risk assessment and hypertension management, but conventional cuff-based ABPM causes discomfort and sleep disturbance, potentially affecting measurement reliability. The European Society of Hypertension (ESH) established evaluation criteria for cuffless blood pressure devices, with the awake/asleep test as the primary evaluation test for automated wearable devices. This study evaluated whether Alysis-001, a software-based cuffless blood pressure estimation algorithm using sensor data from a wrist-worn device, meets ESH awake/asleep test criteria in hypertensive patients under two data extraction strategies: (1) arm-stabilized periods only ( ≥ 10 s static); (2) including low-intensity activity (high-intensity excluded). We prospectively enrolled 92 hypertensive outpatients receiving antihypertensive treatment who simultaneously wore Alysis Wear and underwent conventional 24-h ABPM; 78 completed the study. Under both strategies, Alysis-001 demonstrated excellent agreement with reference ABPM across all measurement periods, with intraclass correlation coefficients exceeding 0.70 for systolic and diastolic blood pressure. Alysis-001 successfully met all ESH awake/asleep test criteria under both strategies: mean difference between awake-asleep blood pressure changes ≤5 mmHg, standard deviation ≤8 mmHg, and correlation coefficients ≥0.70 for both systolic and diastolic blood pressure. Alysis-001 also demonstrated high sensitivity, specificity, and accuracy in identifying non-dippers under both strategies. To our knowledge, this represents the first evaluation of a Device Type 3 cuffless blood pressure algorithm (automated, wearable, demographic-calibrated, not at heart level) meeting ESH awake/asleep test criteria, suggesting Alysis-001's potential as a clinically viable alternative for ambulatory blood pressure monitoring in hypertensive patients.
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