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| Name | Class |
|---|---|
| Aktiia SA | INDUSTRY |
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This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aktiia.product | Device | The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute error for blood pressure | The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for systolic (SYS) and diastolic (DIA) blood pressure in mmHg | up to 24 hours |
| Mean error for blood pressure | The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg | up to 24 hours |
| Standard deviation of the error for blood pressure | The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg | up to 24 hours |
| Mean absolute error for heart rate | The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm | up to 24 hours |
| Mean error for heart rate | The mean error between the Reference and Aktiia.product for heart rate in bpm | up to 24 hours |
| Standard deviation of the error for heart rate | The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics. | Aktiia values acquired during the first day (with ABPM) will be compared to values acquired during other days of the week and a t-test will be performed. The analysis will be repeated for night values. | 1 week |
| Evaluation of patient's satisfaction for the two devices through a survey with multiple questions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réseau Hospitalier Neuchâtelois | Neuchâtel | 2000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39927495 | Derived | Almeida TP, Perruchoud D, Alexandre J, Vermare P, Sola J, Shah J, Marques L, Pellaton C. Evaluation of Aktiia cuffless blood pressure monitor across 24-h, daytime, and night-time measurements versus ambulatory monitoring: a prospective, single-centre observational study. J Hypertens. 2025 Apr 1;43(4):690-697. doi: 10.1097/HJH.0000000000003960. Epub 2025 Feb 7. |
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10-points likert scale survey, an agree-disagree scale with minimum 0 and maximum 10. Minimum value means strong disagreement, maximum value means strong agreement. |
| up to 24 hours |
| Assessment of the calibration stability of Aktiia OBPM algorithms | Use different calibration points going from 1 to 12 weeks | 12 weeks |
| Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program | comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings | 12 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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