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Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
| 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) |
| Estimated 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 : | August 6, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| 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.
|
- 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
| Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
| 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)
| Contact: Josep Sola, PhD | +41797689800 | josep@aktiia.com |
| Switzerland | |
| University of Lausanne Hospitals | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Grégoire Wuerzner, MD +41213141131 gregoire.wuerzner@chuv.ch | |
| Principal Investigator: | Gregoire Wuerzner, MD | CHUV |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||
| First Posted Date ICMJE | July 22, 2019 | ||||
| Last Update Posted Date | May 20, 2021 | ||||
| Actual Study Start Date ICMJE | August 6, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation | ||||
| Official Title ICMJE | Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation | ||||
| 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 | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Screening |
||||
| Condition ICMJE | Blood Pressure | ||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
185 | ||||
| Original Estimated Enrollment ICMJE |
85 | ||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
ARM1 Inclusion Criteria:
Exclusion Criteria:
ARM2 Inclusion Criteria:
Exclusion Criteria:
ARM3 Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 21 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027777 | ||||
| Other Study ID Numbers ICMJE | OBPM_Ambulatory2019 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Aktiia SA | ||||
| Study Sponsor ICMJE | Aktiia SA | ||||
| Collaborators ICMJE | University of Lausanne Hospitals | ||||
| Investigators ICMJE |
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| PRS Account | Aktiia SA | ||||
| Verification Date | May 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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