Brief description of trial (Data source: BASEC)
L’hypertension artérielle (HTA) est le facteur de risque cardiovasculaire le plus fréquent dans la population adulte. L’HTA augmente le risque d’accident vasculaire cérébral (AVC), d’infarctus du myocarde (coeur) et de l’insuffisance cardiaque. Afin de sensibiliser la population à l’hypertension ainsi
qu’améliorer la qualité de la prise en charge des patients atteints de cette maladie, un moyen de mesure simple, confortable, non-invasif et portable permettant la mesure de la pression artérielle hors du milieu médical est souhaitable.
La compagnie suisse, Aktiia S.A., développe un tel dispositif médical. Il s’agit d’un bracelet à capteur optique porté au poignet, qui permet de mesurer les fluctuations de la pression artérielle à long terme sans utiliser le brassard gonflable et sans interférer avec les activités quotidiennes normales de l’utilisateur.
Dans cette étude clinique, nous souhaitons valider les performances du bracelet Aktiia (version calibrée Aktiia.product-G1 et version non calibrée: Aktiia.product-G2) contre une mesure de la pression artérielle effectuée avec double-auscultation. En outre, nous allons évaluer la précision du pouls mesuré avec Aktiia.product-G1 et Aktiia.product-G2 à l'aide de pulse oxymètre au doigt.
Health conditions investigated(Data source: BASEC)
Hypertension
Health conditions
(Data source: WHO)
Blood Pressure
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Pour cette étude nous placerons le bracelet optique Aktiia autour du poignet droit des participants. Les participants vont effectuer une série d’activités simples telles que marcher, rester assis, debout ou allongé selon les indications de l’opérateur de l’étude. Pendant ces activités, la pression artérielle sera mesurée par des spécialistes médicaux entrainés avec la méthode auscultatoire, la méthode de mesure de référence dans le milieu clinique. Le pouls sera mesuré au doigt à l'aide d'un oxymètre. Les procédures pendant la visite 1 dureront 1heure. Les procédures des visites 2-4 dureront 30 minutes.
Interventions
(Data source: WHO)
Device: Aktiia.product-P0
Criteria for participation in trial
(Data source: BASEC)
ARM1:
Sujets âgés de 21 à 65 ans
Acceptant de participer aux 4 rendez-vous de l'étude
ARM 2:
Sujets âgés de 65 à 85 ans
Acceptant de participer aux 4 rendez-vous de l'étude
ARM3:
Sujets diabétiques HbA1c ≥ 6.5% et/ou prenant un traitement contre le diabète (oral ou sous cutané) (Diabète de Type 1 ou Type 2)
Sujets âgés de 21 à 85 ans
Acceptant de participer aux 4 rendez-vous de l'étude
Exclusion criteria
(Data source: BASEC)
- Tachycardie (rythme cardiaque au repos > 120[battements/min])
- Fibrillation auriculaire
- Dysfonctions rénales
- Hyper/hypo- thyroïdie
- Pheochromocytomes
- Maladie de Raynaud
- Paralysie du bras
- Amputation du bras
- Grossesse connue
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 85 Years
Minimum age: 21 Years
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)
-
Further information on trial
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Blood Pressure absolute Mean Error;Blood Pressure standard Deviation of the Erro
Secundary end point
(Data source: WHO)
Heart Rate root-mean-square erro
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Grégoire Wuerzner
+41 21 314 11 31
gregoire.wuerzner@chuv.ch
Contact for general information
(Data source: WHO)
Gregoire Wuerzner, MD;Josep Sola, PhD;Gr?goire Wuerzner, MD
CHUV
+41797689800;+41213141131
josep@aktiia.com;gregoire.wuerzner@chuv.ch
Contact for scientific information
(Data source: WHO)
Gregoire Wuerzner, MD;Josep Sola, PhD;Gr?goire Wuerzner, MD
CHUV
+41797689800;+41213141131
josep@aktiia.com;gregoire.wuerzner@chuv.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
07.08.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01046
Secondary ID (Data source: WHO)
OBPM_Ambulatory2019
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