Evaluation of Alysis-001 cuffless blood pressure estimation algorithm against the European Society of Hypertension awake/asleep test criteria in hypertensive patients.

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.