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Completed

NCT Number: NCT04548986

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)

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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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Réseau Hospitalier Neuchâtelois

Neuchâtel, 2000, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aktiia.product

Device

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

Primary outcomes

  1. Mean absolute error for blood pressure

    Time frame: up to 24 hours

    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

  2. Mean error for blood pressure

    Time frame: up to 24 hours

    The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg

  3. Standard deviation of the error for blood pressure

    Time frame: up to 24 hours

    The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg

  4. Mean absolute error for heart rate

    Time frame: up to 24 hours

    The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm

  5. Mean error for heart rate

    Time frame: up to 24 hours

    The mean error between the Reference and Aktiia.product for heart rate in bpm

  6. Standard deviation of the error for heart rate

    Time frame: up to 24 hours

    The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm

Secondary outcomes

  1. Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.

    Time frame: 1 week

    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.

  2. Evaluation of patient's satisfaction for the two devices through a survey with multiple questions

    Time frame: up to 24 hours

    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.

  3. Assessment of the calibration stability of Aktiia OBPM algorithms

    Time frame: 12 weeks

    Use different calibration points going from 1 to 12 weeks

  4. Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program

    Time frame: 12 weeks

    comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings

Sponsors and collaborators

Lead sponsor

Cyril Pellaton

Other

Collaborators

  • Aktiia SA

Registry information

Acronym: OBPM_ABPM2020

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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