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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 : Completed
First Posted : July 22, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Aktiia SA

Brief Summary:
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Condition or disease Intervention/treatment Phase
Blood Pressure Device: Aktiia.product-P0 Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Primary Completion Date : January 6, 2020
Actual Study Completion Date : January 6, 2020

Arm Intervention/treatment
Experimental: Aktiia.product-P0
Single study arm including 85 subjects
Device: Aktiia.product-P0
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult subjects (aged between 21 and 65 years old)
  • Subjects fluent in written and spoken French
  • Subjects agreeing to attend the totality of 4 visits
  • Subjects that have signed the informed consent form

Exclusion Criteria:

  • Subjects with tachycardia (heart rate at rest > 120bpm)
  • Subjects with atrial fibrillation
  • Subjects with diabetes
  • Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
  • 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
  • Subjects with an arteriovenous fistula
  • Subjects with arm amputations
  • Subjects with the upper arm circumference > 64 cm
  • Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
  • Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
  • Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
  • Subjects with lymphoedema (limitation due to participant discomfort)

Information from the National Library of Medicine

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


Locations
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Switzerland
University of Lausanne Hospitals
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Aktiia SA
University of Lausanne Hospitals

Additional Information:
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Responsible Party: Aktiia SA
ClinicalTrials.gov Identifier: NCT04027777    
Other Study ID Numbers: OBPM_Ambulatory2019
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No