Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Primary Purpose
Hypertension, Blood Pressure, Heart Rate
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aktiia.product-us
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Adult subjects (aged between 21 and 85 years old)
- Subjects can read and speak French
- Subjects can perform simple physical exercises
- Subjects agreeing to attend the totality of 9 visits
- Subjects that have signed the informed consent form
Exclusion Criteria:
- Clinical staff collaborating with study PI
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions
- Subjects with hyper-/hypothyroidism
- 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 (for ARM 1 only)
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference < 22cm or > 42 cm
- Subjects with the wrist circumference > 21 cm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
Sites / Locations
- University of Lausanne HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients 21-60yo with Aktiia.product-us
Patients 60-85yo with Aktiia.product-us
Arm Description
All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.
All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.
Outcomes
Primary Outcome Measures
Blood pressure mean value of differences
The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Secondary Outcome Measures
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-us heart rate determinations and the reference method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05236348
Brief Title
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Official Title
Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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 with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.
Detailed Description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population suffering from hypertension is currently not diagnosed and half of the treated population is not at the defined target of BP.
Widespread use of out-of-office Blood Pressure measurement is one of the proposed strategies to fight against hypertension worldwide.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor, determining the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist.
The goal of this study is to establish a reasonable assurance of safety and effectiveness with Aktiia OBPM system for monitoring blood pressure in home use.
In particular, the study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce Blood Pressure changes, during eight visits that will be held over the span of seven days, and generate performance reports.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure, Heart Rate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All study participants will wear the Aktiia.bracelet-us during 9 visits that will be held over the span of seven days. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises during these visits.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients 21-60yo with Aktiia.product-us
Arm Type
Experimental
Arm Description
All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.
Arm Title
Patients 60-85yo with Aktiia.product-us
Arm Type
Experimental
Arm Description
All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.
Intervention Type
Device
Intervention Name(s)
Aktiia.product-us
Other Intervention Name(s)
Aktiia bracelet, Aktiia product, Aktiia.product
Intervention Description
The study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports.
Primary Outcome Measure Information:
Title
Blood pressure mean value of differences
Description
The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Time Frame
1 week
Title
Blood pressure standard deviation of differences
Description
The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Heart rate root-mean-square error
Description
The root-mean-square difference between the Aktiia.product-us heart rate determinations and the reference method.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult subjects (aged between 21 and 85 years old)
Subjects can read and speak French
Subjects can perform simple physical exercises
Subjects agreeing to attend the totality of 9 visits
Subjects that have signed the informed consent form
Exclusion Criteria:
Clinical staff collaborating with study PI
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions
Subjects with hyper-/hypothyroidism
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 (for ARM 1 only)
Subjects with an arteriovenous fistula
Subjects with arm amputations
Subjects with the upper arm circumference < 22cm or > 42 cm
Subjects with the wrist circumference > 21 cm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Sola, PhD
Phone
+41797689800
Email
josep@aktiia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregoire Wuerzner, MD
Organizational Affiliation
Service of Nephrology and Hypertension CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lausanne Hospitals
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Wuerzner, MD
Phone
+41213141131
Email
gregoire.wuerzner@chuv.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
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