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COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
N/A
Waitlist Available
Led By Naomi Fisher, MD
Research Sponsored by Aktiia SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This Trial will compare the accuracy of the Aktiia Bracelet with traditional home blood pressure monitors over several months. The Aktiia Bracelet is a wrist device that measures blood pressure and heart rate without a cuff, intended for patients in the Remote Hypertension Program. The Aktiia Bracelet is a wrist-worn optical blood pressure monitor that has been tested in previous studies.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
Secondary study objectives
Diastolic and Systolic Pressures Circadian profiles
Quality of life surveys
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Aktiia braceletExperimental Treatment1 Intervention
This is a prospective open-label single arm study. Study participants will wear the Aktiia bracelet for 6 months and will continue in parallel the procedures of the Remote Hypertension Program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aktiia Bracelet
2022
N/A
~60
Find a Location
Who is running the clinical trial?
Aktiia SALead Sponsor
11 Previous Clinical Trials
23,964 Total Patients Enrolled
Naomi Fisher, MDPrincipal InvestigatorHarvard Medical School Boston MA
2 Previous Clinical Trials
325 Total Patients Enrolled