[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100364633":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":74,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":43,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":43,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":43,"overallStatus":58,"whyStopped":43,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Aktiia SA","INDUSTRY",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Aktiia.product-P0","EXPERIMENTAL","Main study arm including 105 subjects",[13],"Device: Aktiia.product-P0",{"label":15,"type":10,"description":16,"interventionNames":17},"Aktiia.product-P0 Diabetics","Second study arm including 40 diabetic patients",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Aktiia.product-P0 Aged","Thirs study arm including 40 patients aged 65+",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Aktiia.product-P0 and subjects with Chronic Kidney disease","Additional study arm including 40 subjects with chronic kidney disease (ARM 4)",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Aktiia.product-P0 and subjects with Heart Failure","Additional study arm including 40 subjects with Heart Failure (ARM 5)",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Aktiia.product-P0 and Pregnant subjects","Additional study arm including 50 pregnant subjects (ARM 6)",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Aktiia.product-P0 and subjects in Post partum","Additional study arm including 40 subjects in post partum (ARM 7)",[13],[39],{"type":40,"name":9,"description":41,"armGroupLabels":42,"otherNames":43},"DEVICE","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.",[9,19,15,31,35,23,27],null,[45],{"name":46,"affiliation":47,"role":48},"Gregoire Wuerzner, MD","CHUV","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":43,"email":54},"Josep Sola, PhD","CONTACT","+41797689800","josep@aktiia.com",[56],{"facility":57,"status":58,"city":59,"state":43,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of Lausanne Hospitals","RECRUITING","Lausanne","1011","Switzerland","CH",{"type":64,"coordinates":65},"Point",[66,67],6.63282,46.516,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":43,"email":73},"Grégoire Wuerzner, MD","+41213141131","gregoire.wuerzner@chuv.ch",{"type":75,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[77],{"name":57,"class":78},"OTHER","100364633","aktiia-opbm-single-center-prospective-observational-study-against-double-auscultation-100364633",false,"NCT04027777","Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation","Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation","ARM1\n\nInclusion Criteria:\n\n* Adult subjects (aged between 21 and 65 years old)\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects with hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 22 cm (limitation due Aktiia.bracelet-P0 size)\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases (limitation due to participant discomfort)\n* Subjects with lymphoedema (limitation due to participant discomfort)\n\nARM2\n\nInclusion Criteria:\n\n* Adult subjects (aged between 21 and 65 years old)\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 22 cm (limitation due Aktiia.bracelet-P0 size)\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases (limitation due to participant discomfort)\n* Subjects with lymphoedema (limitation due to participant discomfort)\n\nARM3\n\nInclusion Criteria:\n\n* Adult subjects (aged between 65 and 85 years old)\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects with hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 22 cm (limitation due Aktiia.bracelet-P0 size)\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases (limitation due to participant discomfort)\n* Subjects with lymphoedema (limitation due to participant discomfort)\n\nARM 4\n\nThe study arm will include:\n\n* Adult subjects aged between 21 and 85 years old\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects residing within 100 km of the CHUV site\n* Subjects able to pedal with an ergocycle\n* Subjects that have signed the informed consent form\n\nThe study will exclude:\n\n* Subjects undergoing dialysis treatment\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with untreated hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 23 cm\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases\n* Subjects with lymphoedema\n\nARM 5\n\nThe study arm will include:\n\n* Adult subjects aged between 21 and 85 years old\n* 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\n* Subjects fluent in written and spoken French\n\nSubjects agreeing to attend the totality of 4 visits\n\n* Subjects residing within 100 km of the CHUV site\n* Subjects able to pedal with an ergocycle\n* Subjects that have signed the informed consent form\n\nThe study will exclude:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects with untreated hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 23 cm\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases\n* Subjects with lymphoedema\n\nARM 6\n\nThe study arm will include:\n\n* Subjects who are adult females aged 21 years or older\n* Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist\n* Subjects not requiring hospitalization\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects residing within 100 km of the CHUV site.\n* Subjects that have signed the informed consent form\n\nThe study will exclude:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects with untreated hyper\u002Fhypotyroidism not related to pregnancy changes\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 23 cm\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases\n* Subjects with lymphoedema\n\nARM 7\n\nThe study arm will include:\n\n* Subjects who are adult females aged 21 years or older\n* Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the totality of 4 visits\n* Subjects residing within 100 km of the CHUV site.\n* Subjects that have signed the informed consent form\n\nThe study will exclude:\n\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions (eGFR \\\u003C 60mL\u002Fmin\u002F1.73 m2)\n* Subjects with untreated hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with trembling and shivering\n* Subjects with interarm systolic difference \\> 15 mmHg\n* Subjects with interarm diastolic difference \\> 10 mmHg\n* Subjects with arm paralysis\n* Women in known pregnancy\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations Subjects with the upper arm circumference \\> 64 cm\n* Subjects with the wrist circumference \\> 23 cm\n* Subjects with the central phalanx of the middle finger circumference \\> 71 mm or \\\u003C 43 mm\n* Subjects with the exfoliative skin diseases\n* Subjects with lymphoedema.",true,"ALL","21 Years","85 Years",{"count":91,"type":92},355,"ESTIMATED","INTERVENTIONAL",[95],"NA","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",[98],"Blood Pressure","2026-03-31",{"date":101,"type":102},"2026-04-06","ACTUAL",{"date":104,"type":102},"2019-08-06",{"date":106,"type":92},"2027-12-31",{"name":5,"class":6},1]