Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05830214
Status:
WITHDRAWN
Last Update Posted:
2024-02-08
First Post:
2023-02-24
Brief Title:
Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS CAPTURE ALS Smarwatch
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty procuring study device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study will use new smartwatch technology to continuously and remotely monitor the health of ALS patients and healthy controls over time This information will be used to develop digital biomarkers for ALS
Detailed Description:
This is an optional study that is conducted in parallel to CAPTURE ALS NCT05204017 In this exploratory prospective longitudinal study CAPTURE ALS participants undergo remote physiological data collection using smartwatch technology Participants will wear a specialized smartwatch Health Gauge AI-Based Wearable Device for the duration of the study ALS patients will be followed for 12 months healthy controls will be followed for 8 months Digital questionnaires will monitor participant-related outcomes bi-monthly Gait assessments will be performed by ambulatory patients and healthy controls in clinic during CAPTURE ALS study visits to measure changes in walking activity
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