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Device
Blood Pressure Monitoring Devices for High Blood Pressure
N/A
Waitlist Available
Led By Erica Spatz
Research Sponsored by Yale University
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 up to 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new wrist-worn device called BIO-Z that measures blood pressure without needing a cuff. It aims to help adults with high blood pressure by providing an easier and more convenient way to monitor their condition. The device will be evaluated to ensure its accuracy.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean absolute difference (MAD) value between Bio-Z wristband and Finapres Nova®.
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: BIO-Z vs. Finapres NovaExperimental Treatment2 Interventions
Participants will have blood pressure in both arms measured three times using standard methods. The investigators will then fit the Bio-Z watch onto the non-dominant hand's wrist and the Finapres Nova® on the middle finger of the arm with the Bio-Z device. Participants will be asked to perform different exercises and blood pressure readings will be recorded during the exercise and recovery. Each exercise will be repeated three times. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation. Each visit will take at most 2 hours to complete study exercises for a total of 6 hours of study time if all the three visits are completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO-Z
2023
N/A
~50
Finapres Nova
2019
N/A
~990
Find a Location
Who is running the clinical trial?
Texas A&M UniversityOTHER
147 Previous Clinical Trials
23,411 Total Patients Enrolled
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,641 Total Patients Enrolled
Texas A&M Engineering Experiment StationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker or irregular heartbeat (A-fib).You are taking medications that can affect a part of your body called the hypothalamic-pituitary-adrenal axis.You are taking four or more medications for high blood pressure.You are in the later stages of pregnancy, 20 weeks or more.If you have a history of high blood pressure or your blood pressure has been consistently high in the past year, you cannot participate.People who have uncontrollable shaking.Your blood pressure is significantly different between your right and left arms.You have been diagnosed with peripheral artery disease.You are receiving dialysis treatment.
Research Study Groups:
This trial has the following groups:- Group 1: BIO-Z vs. Finapres Nova
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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