Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573801
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Centre Randomised Prospective Cross-over Study to Assess Agreement Between Blood Pressure Measurements Taken Using Cuffless Wearable and Cuffed Ambulatory Blood Pressure Monitoring Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Continuum BP
Brief Summary:
Wrist worn devices can help record Blood Pressure BP throughout the day As such devices are becoming increasingly affordable they could help improve awareness early diagnosis and treatment of high and uncontrolled BP
The goal of Continuum BP is to evaluate how BP readings from two different types of wrist-worn cuffless devices available on the market Aktiia and Healthstats BPro Evo compare with BP taken using an ambulatory BP monitor which records readings over 24h using a standard upper arm cuff This interventional study will recruit balanced numbers of male and female participants within different age group who will sequentially wear the Aktiia Bracelet and the Heathstats BPro Evo for a period of 24h alongside the cuffed ambulatory BP monitor
If wrist worn devices are found to measure BP reliably future research will assess if artificial intelligence can use continuous BP readings from these devices to learn patterns and changes in BP and develop digital twin models to guide better more precise BP management for individuals
The goal of Continuum BP is to evaluate how BP readings from two different types of wrist-worn cuffless devices available on the market Aktiia and Healthstats BPro Evo compare with BP taken using an ambulatory BP monitor which records readings over 24h using a standard upper arm cuff This interventional study will recruit balanced numbers of male and female participants within different age group who will sequentially wear the Aktiia Bracelet and the Heathstats BPro Evo for a period of 24h alongside the cuffed ambulatory BP monitor
If wrist worn devices are found to measure BP reliably future research will assess if artificial intelligence can use continuous BP readings from these devices to learn patterns and changes in BP and develop digital twin models to guide better more precise BP management for individuals
Detailed Description:
None
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