[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aktiia SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":227},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,72,93,115,139,161,186,206],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631993","obpmpanda2026-evaluation-of-the-performance-and-safety-of-the-aktiia-periodic-optical-blood-pressure-monitoring-device-100631993",false,"NCT07507903","OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device","OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study","OBPM_PANDA2026","Inclusion Criteria:\n\n1. Participants must be able to provide informed consent to participate.\n2. Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.\n3. Participants must be 22 to 59 years of age.\n4. Participants or witnesses must be able to read or write in English.\n\n   Exclusion Criteria:\n5. Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)\n6. Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential .\n7. Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.\n8. Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.\n9. Participants suffering from sporadic or sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including but not limited to tachycardia (heart rate at rest \\> 120bpm) and atrial fibrillation.\n10. Participants suffering from sporadic or sustained reduction of peripheral perfusion that can lead to weak or unstable pressure pulses including but not limited to: Raynaud's disease, diabetes (Type I and Type II), renal dysfunctions (eGFR \\\u003C 60mL \u002F min \u002F 1.73 m2), hyper- \u002F hypothyroidism, pheochromocytoma, arteriovenous fistula, and valvular heart diseases.\n11. A wrist circumference below 14 cm or above 23 cm.\n12. An upper-arm circumference \\\u003C22 cm or \\> 42cm.\n13. Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.\n14. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and\u002For more than 10 mmHg for the diastolic.",true,"ALL","22 Years","59 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.",[29],"Hypertension",[31],"blood pressure","NOT_YET_RECRUITING","2026-04-14",{"date":35,"type":36},"2026-04-17","ACTUAL",{"date":38,"type":23},"2026-04-20",{"date":40,"type":23},"2026-12-31",{"name":42,"class":43},"Aktiia SA","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100633175","wearable-bp-wearable-everyday-automated-readings-to-enable-assessment-of-blood-pressure-control-100633175","NCT07523269","WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control","WEARABLE-BP","Inclusion Criteria:\n\n* Adults aged 21 to 85 years.\n* Able to read and speak English.\n* Have an MGB provider and medical record number in EPIC\n* Study participants will wear the Aktiia bracelet for 6 months\n* Willing to attend two on-site study visits and comply with all study procedures.\n* Signed informed consent provided.\n* Own a smartphone with iOS or Android operating system.\n* Hypertensive with uncontrolled systolic blood pressure (SBP) \\>135 mm Hg by unattended automated office measurement\n* Currently taking 0, 1 or 2 antihypertensive medications.\n\nExclusion Criteria:\n\n* Severe hypertension (SBP \\> 180 mmHg or DBP \\> 120 mmHg).\n* Pregnant or breastfeeding.\n* Known severe heart failure (LVEF \\\u003C 35%).\n* Known severe valvular heart disease.\n* Known pheochromocytoma.\n* Known severe chronic kidney disease (CKD stage 4-5; eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n* Known uncontrolled hyperthyroidism or hypothyroidism.\n* Known severe diabetes (Hemoglobin A1c \\> 10%).\n* Known resting heart rate \\> 120 bpm.\n* Known persistent atrial fibrillation.\n* Known Raynaud's disease.\n* Known tremors or shivering disorders.\n* Known exfoliative skin diseases.\n* Known allergy to silicone.\n* Presence of lymphedema.\n* Paralysis of the arm.\n* Arm amputation.\n* Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.\n* Upper arm circumference \\\u003C 22 cm or \\> 42 cm.\n* Wrist circumference \\> 23 cm.\n* Mastectomy","21 Years","85 Years",{"count":55,"type":23},164,[26],"The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring.\n\nThe WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.",[59],"Hypertension (HTN)",[61,62,29],"Vascular Diseases","Cardiovascular Diseases","RECRUITING","2026-04-08",{"date":66,"type":36},"2026-04-13",{"date":68,"type":23},"2026-04",{"date":70,"type":23},"2027-12",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100364633","aktiia-opbm-single-center-prospective-observational-study-against-double-auscultation-100364633","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.",{"count":80,"type":23},355,[26],"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",[84],"Blood Pressure","2026-03-31",{"date":87,"type":36},"2026-04-06",{"date":89,"type":36},"2019-08-06",{"date":91,"type":23},"2027-12-31",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":101,"targetDuration":4,"studyType":24,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":113,"locationsCount":114},"100499242","obpmmeds2023-multicentric-prospective-clinical-study-to-evaluate-the-aktiia-optical-blood-pressure-monitoring-obpm-device-compared-to-standard-home-blood-pressure-monitoring-hbpm-in-hypertensive-patients-when-blood-pressure-lowering-medications-intake-100499242","NCT05780710","OBPM_Meds2023: Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake","Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake","OBPM_Meds2023","Inclusion Criteria:\n\n1. Adult subjects aged 21 to 85 years old\n2. Subjects that can read and speak French\n3. Subjects that own a smart phone that uses either the iOS or Android operating system\n4. Hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged \\> 65yo SBP ≥160 mmHg,\n5. Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs\n6. Subjects agreeing to attend all 4 on-site visits and follow study procedures\n7. Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n1. Subjects have contraindications to the study drugs\n2. Subjects with Hypertension Stage 3 (SBP\u002FDBP \\>180\u002F110 mmHg)\n3. Subjects with orthostatic hypotension (a 20 mmHg decrease in systolic BP, or 10 mmHg decrease in diastolic BP when measured in the standing position after a 1-minute waiting period)\n4. Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11\n\n   a.m. and 4 to 9 p.m.).\n5. Subjects having medical interventions or taking treatments during the study that could have an impact on their BP\n6. For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and\u002F or, albumin\u002Fcreatinine ratio in urine ≥3.5 mg\u002Fmmol)\n7. Subjects with tachycardia (heart rate at rest \\> 120bpm)\n8. Subjects with atrial fibrillation\n9. Cardio myopathy (FE\\\u003C40%)\n10. Severe valvular disease\n11. Implanted devices such as a pacemaker or defibrillator\n12. Subjects with diabetes\n13. Subjects with renal dysfunctions (eGFR \\\u003C 45mL\u002Fmin\u002F1.73 m2 for patients between 21-85 yo)\n14. Subjects with hyper-\u002Fhypothyroidism\n15. Subjects with pheochromocytoma\n16. Subjects with Raynaud's disease\n17. Subjects with an arteriovenous fistula\n18. Women in known pregnancy\n19. Subjects with trembling and shivering\n20. Subjects with lymphoedema\n21. Low or elevated potassium level: threshold ≤3.5 mmol\u002FL or ≥4.8 mmol\u002FL\n22. Presence of an intravascular device\n23. Subjects with exfoliative skin diseases\n24. Subjects with arm paralysis\n25. Subjects with arm amputation\n26. Subjects with upper arm circumference \\\u003C 22cm or \\> 42cm\n27. Subjects with wrist circumference \\> 23cm\n28. Subjects with non-standard circadian rhythm, including shift workers and night workers\n29. Subjects who have received a mastectomy.",{"count":102,"type":23},35,[26],"Study design: Prospective, multicentric, randomized, comparative study Study duration: between 4 and 19 weeks depending on the study group. Population: minimum 35 hypertensives (stage 1 or stage 2) participants divided into 3 groups depending on hypertension criteria. GROUP 1 = untreated hypertensives, stage 1 or stage 2; GROUP 2 = hypertensives, stage 1, who are taking antihypertensive monotherapy; GROUP 3 = hypertensives, stage 1 or stage 2, who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.\n\nDevice Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: For GROUPS 1 and 2, 2 weeks of treatment for each antihypertensive medication followed by a washout period of 2 weeks (3 antihypertensive medications in total with a fixed dose; medication intake order is randomly assigned). For GROUP 3, an individualized new antihypertensive medication will be prescribed during the consultation with the investigator that will be administered for 3 weeks.",[29],[29,84],"2026-02-04",{"date":109,"type":36},"2026-02-05",{"date":111,"type":36},"2023-06-29",{"date":40,"type":23},{"name":42,"class":43},3,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100600609","obpmharmony-physiological-data-recording-over-24-hours-using-the-continual-optical-hilo-blood-pressure-monitor-and-an-ambulatory-blood-pressure-monitor-100600609","NCT07099716","OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor","Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor: a Single-center, Prospective Clinical Study.","OBPM_HARMONY","Inclusion Criteria:\n\n* Subjects aged 21 to 85yo\n* Subjects fluent in written and spoken French, capable of discernment\n* Subjects agreeing to attend the two study visits and follow study procedures\n* Subjects residing within 100 km of the CHUV site\n* Subjects that have signed the informed consent form.\n\nExclusion Criteria\n\n* Damaged\u002Finjured skin at the right wrist\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with marked renal dysfunctions\n* Subjects with untreated hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with an arteriovenous fistula\n* Subjects with implanted electrical devices, such as cardiac pacemakers or defibrillators\n* Subjects with premature ventricular beats\n* Subjects with peripheral arterial disease\n* Subjects undergoing intravascular therapy or arterio-venous shunt\n* Subjects who have received a mastectomy\n* Women in known pregnancy or women with pre-eclampsia\n* Subjects of unsound mind\n* Subjects with upper arm circumference \\\u003C 22cm or \\> 42cm\n* Subjects with wrist circumference \\\u003C14cm or \\> 23cm\n* A lateral difference in systolic blood pressure \\>15 mmHg or diastolic blood pressure \\>10 mmHg between arms.",{"count":124,"type":23},330,"OBSERVATIONAL","The OBPM\\_HARMONY study will enroll a minimum of 300 participants at the CHUV site in Lausanne, Switzerland. Each participant will complete two study visits at CHUV, scheduled at least 24.5 hours apart. Between these visits, participants will be asked to wear both the Hilo band, an Ambulatory Blood Pressure Monitor (ABPM) as well as a hydrostatic pressure system continuously for a 24-hour period.",[29],[129,29,130],"HARMONY","CHUV","2025-09-08",{"date":133,"type":36},"2025-09-12",{"date":135,"type":23},"2025-09-15",{"date":137,"type":23},"2026-05-15",{"name":42,"class":43},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":160,"locationsCount":44},"100569768","obpmcoyote2024-physiological-data-recording-with-the-calibration-free-optical-aktiia-g2c-device-at-fingertip-and-wrist-alongside-the-aktiia-oscillometric-cuff-100569768","NCT06698536","OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff","OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff: a Single-center, Prospective Clinical Study","COYOTE2024","Inclusion Criteria:\n\n* Subjects aged 21 to 85yo\n* Subjects or witnesses fluent in written and spoken French\n* Subjects agreeing to attend the study visit and follow study procedures\n* Subjects that have signed the informed consent form.\n\nExclusion Criteria:\n\n* Amputated index fingers\n* Damaged\u002Finjured skin at index fingers\n* Damaged\u002Finjured skin at wrists\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with marked renal dysfunctions (eGFR \\\u003C 30mL\u002Fmin\u002F1.73 m2)\n* Subjects with untreated hyper-\u002Fhypothyroidism\n* Subjects with pheochromocytoma\n* Subjects with Raynaud's disease\n* Subjects with an arteriovenous fistula\n* Women in known pregnancy\n* History of polyneuropathy",{"count":148,"type":23},255,[26],"The present study, OBPM\\_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting \\~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.",[29],[153,31],"hypertension","2025-05-12",{"date":156,"type":36},"2025-05-14",{"date":158,"type":36},"2024-12-20",{"date":40,"type":23},{"name":42,"class":43},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":169,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100567629","evaluation-of-the-clinical-benefit-of-the-aktiia-blood-pressure-monitoring-for-early-awareness-of-hypertension-and-prediction-of-cardiovascular-risk-100567629","NCT06670677","Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk","OBPM_FORESEE2024: Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk in a Multi-ethnic European Population: an Observational Cohorts' Study","FORESEE2024","Inclusion Criteria:\n\n1. Adult subjects aged 21 to 85 years old\n2. Subjects living in Switzerland, Germany or in the UK\n3. Subjects that are:\n\n   Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3)\n4. Subjects agreeing to follow the study procedures.\n\nExclusion Criteria:\n\n1. Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest \\> 120bpm) and atrial fibrillation;\n2. Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \\\u003C 30mL \u002F min \u002F 1.73 m2), untreated hyper-\u002F hypothyroidism, pheochromocytoma, or arteriovenous fistula;\n3. Subjects suffering from polyneuropathy;\n4. on pregnant women;\n5. Subjects with damaged \u002F injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)\n6. Subjects with amputated index fingers (for camera measurements) or amputated upper limb;\n7. Subjects below 21 years old and above 85 years old.",{"count":170,"type":23},15000,"Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.",[29,173,174],"Cardiovascular Risk","Blood Pressure Check (Hypertension Screening)",[153,31,176,177,178,179],"Hypertensive","cardiovascular diseases","cardiovascular risk","prediction",{"date":156,"type":36},{"date":154,"type":36},{"date":183,"type":23},"2035-05-31",{"name":42,"class":43},2,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":44},"100544386","recording-of-physiological-data-via-an-optical-sensor-at-the-fingertip-alongside-with-double-auscultatory-and-pulse-oximetry-to-evaluate-the-effectiveness-of-an-optical-blood-pressure-monitoring-obpm-100544386","NCT06368206","Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)","Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study","Inclusion Criteria:\n\n* Subjects aged 21 to 85yo\n* Subjects fluent in written and spoken French\n* Subjects agreeing to attend the study visit and follow study procedures\n* Subjects that have signed the informed consent form.\n\nExclusion Criteria:\n\n* Amputated index fingers\n* Damaged\u002Finjured skin at index fingers\n* Damaged\u002Finjured skin at wrists\n* Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \\> 120bpm) and atrial fibrillation\n* Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \\\u003C 30mL\u002Fmin\u002F1.73 m2), hyper-\u002Fhypothyroidism, pheochromocytoma or arteriovenous fistula\n* Pregnant women\n* Polyneuropathy",{"count":194,"type":23},85,[26],"The present study, OBPM\\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.",[29],"2024-12-12",{"date":200,"type":36},"2024-12-17",{"date":202,"type":36},"2024-06-25",{"date":204,"type":23},"2025-12-31",{"name":42,"class":43},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":213,"targetDuration":4,"studyType":24,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":44},"100457419","performance-of-the-aktiia-optical-blood-pressure-monitoring-device-against-double-auscultation-100457419","NCT05236348","Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation","Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation","Inclusion Criteria:\n\n* Adult subjects (aged between 21 and 85 years old)\n* Subjects can read and speak French\n* Subjects can perform simple physical exercises\n* Subjects agreeing to attend the totality of 9 visits\n* Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n* Clinical staff collaborating with study PI\n* Subjects with tachycardia (heart rate at rest \\> 120bpm)\n* Subjects with atrial fibrillation\n* Subjects with diabetes\n* Subjects with renal dysfunctions\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 (for ARM 1 only)\n* Subjects with an arteriovenous fistula\n* Subjects with arm amputations\n* Subjects with the upper arm circumference \\\u003C 22cm or \\> 42 cm\n* Subjects with the wrist circumference \\> 21 cm\n* Subjects with the exfoliative skin diseases\n* Subjects with lymphoedema",{"count":214,"type":23},225,[26],"This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.",[29,84,218],"Heart Rate","2024-08-16",{"date":221,"type":36},"2024-08-19",{"date":223,"type":36},"2022-01-11",{"date":225,"type":23},"2025-03-31",{"name":42,"class":43},""]