Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Sponsor

Aktiia SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04027777

Collaborator

University of Lausanne Hospitals (Other)

185

Enrollment

Location

Arms

40.8

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

185 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel 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 :

Aug 6, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aktiia.product-P0 Main 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.
Experimental: Aktiia.product-P0 Diabetics Second study arm including 40 diabetic patients	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.
Experimental: Aktiia.product-P0 Aged Thirs study arm including 40 patients aged 65+	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.

Arm

Intervention/Treatment

Experimental: Aktiia.product-P0

Main 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.

Experimental: Aktiia.product-P0 Diabetics

Second study arm including 40 diabetic patients

Device: Aktiia.product-P0

Experimental: Aktiia.product-P0 Aged

Thirs study arm including 40 patients aged 65+

Device: Aktiia.product-P0

Outcome Measures

Primary Outcome Measures

Blood Pressure absolute Mean Error [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 [Up to four weeks]
The standard deviation of the differences between Reference and Aktiia.product-P0 determinations

Secondary Outcome Measures

Heart Rate root-mean-square error [Up to four weeks]
The root-mean-square difference between the Aktiia.product-P0 heart rate determinations and the Reference method

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

ARM1

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)

ARM2

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 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)

ARM3

Inclusion Criteria:

Adult subjects (aged between 65 and 85 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Lausanne Hospitals	Lausanne		Switzerland	1011

Sponsors and Collaborators

Aktiia SA
University of Lausanne Hospitals

Investigators

Principal Investigator: Gregoire Wuerzner, MD, CHUV

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Sponsor website

Publications

None provided.

Responsible Party:

Aktiia SA

ClinicalTrials.gov Identifier:

NCT04027777

Other Study ID Numbers:

OBPM_Ambulatory2019

First Posted:

Jul 22, 2019

Last Update Posted:

Feb 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 3, 2022