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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) (OBPM_ABPM2020)

Primary Purpose

Blood Pressure, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aktiia.product
Sponsored by
Cyril Pellaton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Blood Pressure

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Réseau Hospitalier Neuchâtelois

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm

Arm Description

single arm study

Outcomes

Primary Outcome Measures

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
Mean error for blood pressure
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
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
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
Mean error for heart rate
The mean error between the Reference and Aktiia.product for heart rate in bpm
Standard deviation of the error for heart rate
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm

Secondary Outcome Measures

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.
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.
Assessment of the calibration stability of Aktiia OBPM algorithms
Use different calibration points going from 1 to 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

Full Information

First Posted
August 26, 2020
Last Updated
January 23, 2023
Sponsor
Cyril Pellaton
Collaborators
Aktiia SA
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1. Study Identification

Unique Protocol Identification Number
NCT04548986
Brief 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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cyril Pellaton
Collaborators
Aktiia SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypertension

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Other
Arm Description
single arm study
Intervention Type
Device
Intervention Name(s)
Aktiia.product
Intervention Description
The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
Primary Outcome Measure Information:
Title
Mean absolute error for blood pressure
Description
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
Title
Mean error for blood pressure
Description
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Time Frame
up to 24 hours
Title
Standard deviation of the error for blood pressure
Description
The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg
Time Frame
up to 24 hours
Title
Mean absolute error for heart rate
Description
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
Title
Mean error for heart rate
Description
The mean error between the Reference and Aktiia.product for heart rate in bpm
Time Frame
up to 24 hours
Title
Standard deviation of the error for heart rate
Description
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.
Description
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
Title
Evaluation of patient's satisfaction for the two devices through a survey with multiple questions
Description
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
Title
Assessment of the calibration stability of Aktiia OBPM algorithms
Description
Use different calibration points going from 1 to 12 weeks
Time Frame
12 weeks
Title
Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program
Description
comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Réseau Hospitalier Neuchâtelois
City
Neuchâtel
ZIP/Postal Code
2000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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