Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04027777|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2019
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure||Device: Aktiia.product-P0||Not Applicable|
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population is not diagnosed, and half of the treated population is not at the defined target of BP. Widespread use of out of office BP measurement is one of the proposed strategies to fight against hypertension worldwide.
The current Ambulatory Blood Pressure Monitoring or Home Blood Pressure Monitoring are performed with a cuff placed around the arm. This 110-year-old technology is not only uncomfortable for the patient but can also result in a number of overestimated readings due to the stress induced while inflating the cuff.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor determining over a series of cardiac cycles 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 optical sensors integrated within the device exploit the principle of reflection photoplethysmography (PPG) to capture the user's skin pulsatility (change of arterial diameter occurring at each heartbeat). Aktiia OBPM algorithms are further applied to the recorded PPG signal to determine user's blood pressure and heart rate.
Because the measurement relies on optical sensors, and not on pneumatic cuffs, Aktiia OBPM device provides an increased overall comfort to the patient throughout the monitoring, does not induce sleep arousal during the night measurements and decreases the false positive readings induced by the stress associated with the cuff inflation. Aktiia OBPM device is intended to be used in the long term, as compared to one-day or one-week use of Ambulatory Blood Pressure Monitors.
This study over several visits has been designed to assess both the accuracy and the stability of the Aktiia OBPM. The automaticity of the measurement when performed in different body positions and upon aerobic exercise was also evaluated.
By demonstrating both the accuracy and the stability of the measurements that can be performed in different body positions with a comfortable and miniature Aktiia OBPM device, Aktiia SA aims to make one step further in facilitating blood pressure measurement and monitoring in the out-of-clinic scenarios and integrating blood pressure monitoring into user's daily life. The diagnosis and treatment of hypertension in ambulatory settings is expected to largely benefit from these advancements
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation|
|Actual Study Start Date :||August 6, 2019|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
Single study arm including 85 subjects
The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.
- Blood Pressure absolute Mean Error [ Time Frame: Up to four weeks ]The absolute value of the mean of the differences between Reference and Aktiia.product-P0 blood pressure determinations
- Blood Pressure standard Deviation of the Error [ Time Frame: Up to four weeks ]The standard deviation of the differences between Reference and Aktiia.product-P0 determinations
- Heart Rate root-mean-square error [ Time Frame: Up to four weeks ]The root-mean-square difference between the Aktiia.product-P0 heart rate determinations and the Reference method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027777
|University of Lausanne Hospitals|
|Lausanne, Switzerland, 1011|