Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610448
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Wearable Evaluation of Ambulatory Readings for Blood Pressure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Wearable Evaluation of Ambulatory Readings for Blood Pressure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEAR-BP
Brief Summary:
The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure BP and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring ABPM device
Detailed Description:
The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible Knowledge from this project will inform subsequent research protocols among adults and under-represented groups
Up to 250 participants at least 100 will be involved in this study each wearing up to 7 devices 6 BP devices and 1 activity monitor The assignment of devices will be randomized by day and by the arm or wrist on which they are worn During the first visit participants will provide their consent and be randomly fitted with 3 BP devices either the Spacelabs ABPM device or the ABPMpro device the Aktiia wristband BP monitor and one of two other cuff-based wrist BP monitors along with an activity monitor to track body positions These devices will be worn continuously for at least 24-hours including overnight before being returned On the following day for Visit 2 participants will be fitted with a different set of 3 BP devices the ABPMpro device or Spacelabs ABPM device the Aktiia wristband BP device on the opposite wrist from the previous day and the final cuff-based wristband BP device Additionally participants will wear an ambulatory BP device as a patch on the chest These devices will also be worn for at least 24 hours This study will enable characterization of the feasibility practicality and effectiveness of the measurements and the devices39 accuracy and precision
Up to 250 participants at least 100 will be involved in this study each wearing up to 7 devices 6 BP devices and 1 activity monitor The assignment of devices will be randomized by day and by the arm or wrist on which they are worn During the first visit participants will provide their consent and be randomly fitted with 3 BP devices either the Spacelabs ABPM device or the ABPMpro device the Aktiia wristband BP monitor and one of two other cuff-based wrist BP monitors along with an activity monitor to track body positions These devices will be worn continuously for at least 24-hours including overnight before being returned On the following day for Visit 2 participants will be fitted with a different set of 3 BP devices the ABPMpro device or Spacelabs ABPM device the Aktiia wristband BP device on the opposite wrist from the previous day and the final cuff-based wristband BP device Additionally participants will wear an ambulatory BP device as a patch on the chest These devices will also be worn for at least 24 hours This study will enable characterization of the feasibility practicality and effectiveness of the measurements and the devices39 accuracy and precision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None