Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441825
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-05
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:
POWER-MG
Brief Summary:
This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques By integrating digital biomarkers alongside clinical monitoring we aim to enhance the detection of disease activity and establish correlations between digital measures clinical scores and various questionnaires including sores on quality of life sleep quality or activities of daily living Primarily including patients treated with newly approved drugs it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment
Detailed Description:
Myasthenia Gravis MG is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction Typically symptomatic assessments occur during clinical encounters either as part of routine treatment assessments or in acute situations such as myasthenic crises However for a comprehensive understanding of mechanisms in MG and disease activity continuous monitoring is essential
Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures clinical scores such as the QMG scale and MGC as well as various questionnaires addressing sleep quality quality of life or activities of daily living
Data recorded by the used wearables Withings Scanwatch 2 cover various parameters including activity-related data step count minutes in certain intensity levels basic cardiovascular measurements such as heart rate and sleep-related data total time asleep sleep quality etc
Prospectively this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments particularly of the newly approved drugs for MG
In the future wearables might hold the potential to improve treatment processes and optimize therapeutic approaches For instance digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena paving the way for personalized treatment strategies tailored to individual patient needs
Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures clinical scores such as the QMG scale and MGC as well as various questionnaires addressing sleep quality quality of life or activities of daily living
Data recorded by the used wearables Withings Scanwatch 2 cover various parameters including activity-related data step count minutes in certain intensity levels basic cardiovascular measurements such as heart rate and sleep-related data total time asleep sleep quality etc
Prospectively this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments particularly of the newly approved drugs for MG
In the future wearables might hold the potential to improve treatment processes and optimize therapeutic approaches For instance digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena paving the way for personalized treatment strategies tailored to individual patient needs
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