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Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
Sponsor: Aktiia SA
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
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
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
355
Start Date
2019-08-06
Completion Date
2027-12-31
Last Updated
2026-04-06
Healthy Volunteers
Yes
Conditions
Interventions
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.
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) ARM 4 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * Subjects undergoing dialysis treatment * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with untreated 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 \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 5 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI * Subjects fluent in written and spoken French Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * 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 untreated 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 \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 6 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist * Subjects not requiring hospitalization * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * 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 untreated hyper/hypotyroidism not related to pregnancy changes * 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 7 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * 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 untreated 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 \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema.
Locations (1)
University of Lausanne Hospitals
Lausanne, Switzerland