NCT04548986

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

August 26, 2020

Last Update Submit

January 23, 2023

Conditions

Blood PressureHypertension

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (4)

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

    1 week

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

    up to 24 hours

  • Assessment of the calibration stability of Aktiia OBPM algorithms

    12 weeks

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

    12 weeks

Study Arms (1)

single arm

OTHER

single arm study

Device: Aktiia.product

Interventions

Aktiia.productDEVICE

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

single arm

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Réseau Hospitalier Neuchâtelois

Neuchâtel, 2000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 39927495DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cyril Pellaton

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 16, 2020

Study Start

August 6, 2020

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)