Descrizione riassuntiva della sperimentazione (Fonte di dati: 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.
Malattie studiate(Fonte di dati: BASEC)
Hypertension
Health conditions
(Fonte di dati: WHO)
Blood Pressure
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: 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
(Fonte di dati: WHO)
Device: Aktiia.product-P0
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: 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
Criteri di esclusione
(Fonte di dati: 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
(Fonte di dati: 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)
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Recruiting
Titolo scientifico
(Fonte di dati: 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
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
N/A
Punti finali primari
(Fonte di dati: WHO)
Blood Pressure absolute Mean Error;Blood Pressure standard Deviation of the Erro
Punti finali secondari
(Fonte di dati: WHO)
Heart Rate root-mean-square erro
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Losanna
Paesi di esecuzione
(Fonte di dati: WHO)
Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Grégoire Wuerzner
+41 21 314 11 31
gregoire.wuerzner@chuv.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Gregoire Wuerzner, MD;Josep Sola, PhD;Gr?goire Wuerzner, MD
CHUV
+41797689800;+41213141131
josep@aktiia.com;gregoire.wuerzner@chuv.ch
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Gregoire Wuerzner, MD;Josep Sola, PhD;Gr?goire Wuerzner, MD
CHUV
+41797689800;+41213141131
josep@aktiia.com;gregoire.wuerzner@chuv.ch
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Data di autorizzazione da parte della commissione d’etica
07.08.2019
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2019-01046
Secondary ID (Fonte di dati: WHO)
OBPM_Ambulatory2019
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