An interventional study of Aktiia.product in Blood Pressure and Hypertension, sponsored by Cyril Pellaton. Completed at 1 site in Switzerland. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Cyril Pellaton · Not applicable, Interventional, and Screening
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 63 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Cyril Pellaton as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single arm study
Device: Aktiia.product
The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
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
Time frame: up to 24 hours
Mean error for blood pressure
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Time frame: 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
Time frame: 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
Time frame: up to 24 hours
Mean error for heart rate
The mean error between the Reference and Aktiia.product for heart rate in bpm
Time frame: 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
Time frame: up to 24 hours
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.
Time frame: 1 week
Evaluation of patient's satisfaction for the two devices through a survey with multiple questions
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.
Time frame: up to 24 hours
Assessment of the calibration stability of Aktiia OBPM algorithms
Use different calibration points going from 1 to 12 weeks
Time frame: 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
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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