Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)

Hypertension Clinical Trial

— OBPM_ABPM2020  

Official title:

Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548986
• Other study ID #: OBPM_ABPM2020
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2023
• Source: Hopital Neuchatelois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult subjects (aged between 21 and 65)

• Subjects fluent in written and spoken French

• Subjects enrolled in a 12-weeks cardiac rehabilitation program

• Subjects agreeing to participate

• Subjects that have signed the informed consent form

Exclusion Criteria:

• Subjects with tachycardia (heart rate at rest > 120bpm)

• Subjects with atrial fibrillation

• Subjects with severe heart failure (LVEF<35%)

• Subjects with severe renal dysfunctions (eGFR < 30mL/min/1.73 m2)

• Subjects with pheochromocytoma

• Subjects with Raynaud's disease

• Subjects with trembling and shivering

• Subjects with interarm systolic difference > 15 mmHg

• Subjects with interarm diastolic difference > 10 mmHg

• Subjects with arm paralysis

• Women in known pregnancy

• Subjects with an arteriovenous fistula

• Subjects with arm amputations

• Subjects with the upper arm circumference > 64 cm

• Subjects with the wrist circumference > 22 cm

• Subjects with the exfoliative skin diseases

• Subjects with lymphoedema

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Device:
• Aktiia.product
The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.

Locations

Country	Name	City	State
Switzerland	Réseau Hospitalier Neuchâtelois	Neuchâtel

Sponsors (2)

Lead Sponsor	Collaborator
Cyril Pellaton	Aktiia SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean error for blood pressure	The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg	up to 24 hours
Primary	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
Primary	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
Primary	Mean error for heart rate	The mean error between the Reference and Aktiia.product for heart rate in bpm	up to 24 hours
Primary	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
Secondary	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
Secondary	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.	up to 24 hours
Secondary	Assessment of the calibration stability of Aktiia OBPM algorithms	Use different calibration points going from 1 to 12 weeks	12 weeks
Secondary	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