Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335264
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Screening for Heart Failure Using a Multimodal Wearable Device
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Screening for Heart Failure Using a Multimodal Wearable Device
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WEAR-HF
Brief Summary:
The purpose of this study is to find out if there are any patterns in the way peoples bodies react to physical activities and their voices when they have heart failure a disease where the heart cannot function sufficiently To do this the investigators will use a smartwatch that can measure multiple signals like the participants heart rate and movement Investigators will ask participants with and without heart failure to wear the Watch HOP from HOP-Child Technologies Inc and sensors during physical tasks at their clinic visit at the McGill University Health Centre Researchers will also record the participants voices between their visits The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it
Detailed Description:
Heart Failure HF is a multi-faceted and life-threatening syndrome characterized by significant morbidity and mortality poor functional capacity and quality of life and high costs Logistic and economic difficulties prove screening for HF challenging for some populations such as people with reduced mobility and the elderly Sensor technologies and data processing algorithms including artificial intelligence represent an opportunity to systematically identify patients suffering from HF as a complementary tool for echocardiography The ability to compute digital biomarkers using complex models from wearable data requires identifying the key parameters that are associated with the presence of HF A multisensorial wearable device can be utilized to develop digital biomarkers for population-based screening of HF The present study aims to evaluate the best signals from a wearable device to identify digital signals aka digital biomarkers that are most associated with HF including all ejection fraction types
For this study investigators will recruit 27 participants with HF and 27 without HF The primary objective of this study is to analyze the key physiological parameters recorded from the platform devices that can develop a digital biomarker for the presence of prevalent HF
For this study investigators will recruit 27 participants with HF and 27 without HF The primary objective of this study is to analyze the key physiological parameters recorded from the platform devices that can develop a digital biomarker for the presence of prevalent HF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None