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Peer-reviewedCC BY 4.0Hypertension Research

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

  • Kazuhiro Hongyo1
  • Atsushi Hirayama2
  • Kosuke Shimizu3
  • Taisuke Ueno1
  • Taku Fujimoto1
  • Akitoshi Hara1
  • Hiroshi Koriyama1
  • Yoichi Takami1
  • Yoshio Iwashima1
  • Ryo Kawasaki2
  • Koichi Yamamoto1
  1. 1Department of Geriatric and General Medicine, Graduate School of Medicine, The University of Osaka, Suita, Japan
  2. 2Division of Public Health, Department of Social Medicine, Graduate School of Medicine, The University of Osaka, Suita, Japan
  3. 3Arblet Inc., Tokyo, Japan
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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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Cite

BibTeXRIS
BibTeX
@article{hongyo2026evaluation,
  title = {{Evaluation of Alysis-001 cuffless blood pressure estimation algorithm against the European Society of Hypertension awake/asleep test criteria in hypertensive patients}},
  author = {Kazuhiro Hongyo and Atsushi Hirayama and Kosuke Shimizu and Taisuke Ueno and Taku Fujimoto and Akitoshi Hara and Hiroshi Koriyama and Yoichi Takami and Yoshio Iwashima and Ryo Kawasaki and Koichi Yamamoto},
  journal = {Hypertension Research},
  year = {2026},
  month = aug,
  doi = {10.1038/s41440-026-02728-z},
  url = {https://doi.org/10.1038/s41440-026-02728-z},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Evaluation of Alysis-001 cuffless blood pressure estimation algorithm against the European Society of Hypertension awake/asleep test criteria in hypertensive patients
AU  - Kazuhiro Hongyo
AU  - Atsushi Hirayama
AU  - Kosuke Shimizu
AU  - Taisuke Ueno
AU  - Taku Fujimoto
AU  - Akitoshi Hara
AU  - Hiroshi Koriyama
AU  - Yoichi Takami
AU  - Yoshio Iwashima
AU  - Ryo Kawasaki
AU  - Koichi Yamamoto
PY  - 2026
DA  - 2026/08/21
JO  - Hypertension Research
DO  - 10.1038/s41440-026-02728-z
UR  - https://doi.org/10.1038/s41440-026-02728-z
AB  - 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.
SN  - 0916-9636
SN  - 1348-4214
ER  -