Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723848
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2023-01-10
Brief Title:
Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
A Prospective Study to Evaluate the Usefulness of Electronically Captured Wearable Data to Assess Disease Activity in CIDP Chronic Inflammatory Demyelinating Polyneuropathy Patients Undergoing IVIG Intravenous Immunoglobulin Treatment
Status:
COMPLETED
Status Verified Date:
2024-07
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:
EMDA CIDP
Brief Summary:
This clinical prospective study aims to evaluate the usefulness of electronically captured wearable data to assess disease activity in CIDP chronic inflammatory demyelinating polyneuropathy patients undergoing IVIG treatment Close clinical monitoring will complement smartwatch-acquired data to shed light on different patient clusters and end-of-dose phenomena
Detailed Description:
CIDP is a rare chronic neurological condition that leads to a considerable patient burden As symptoms are often challenging to monitor finding an individually optimal treatment regimen can be challenging Additionally patients receiving treatment often describe individual end-of-dose-phenomena frequently leading to uncertainty regarding treatment intervals Digital smartwatch-based measurements could add high-frequency real-world data to the picture and thus improve the understanding of individual disease courses
Consequently this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in CIDP patients treated with intravenous immunoglobulins Firstly digital and blood-based measures will be compared to subjective patient reports and established clinical scores Secondly explorative analyses will aim to understand the longitudinal disease course and fluctuations thereof
Data captured by the used smartwatches Withings Scanwatch includes 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 Blood-based measurements include serum neurofilament-light-chain sNfL glial fibrillary acidic protein GFAP and proteomic data The investigators aim is to show can show whether therapy-dependent activity patterns such as the end-of-dose phenomenon are reflected in the recorded data
Optionally the digital signatures of CIDP patients will be compared to these of healthy controls wearing the smartwatch
Patients were recruited in Düsseldorf and Münster
Consequently this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in CIDP patients treated with intravenous immunoglobulins Firstly digital and blood-based measures will be compared to subjective patient reports and established clinical scores Secondly explorative analyses will aim to understand the longitudinal disease course and fluctuations thereof
Data captured by the used smartwatches Withings Scanwatch includes 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 Blood-based measurements include serum neurofilament-light-chain sNfL glial fibrillary acidic protein GFAP and proteomic data The investigators aim is to show can show whether therapy-dependent activity patterns such as the end-of-dose phenomenon are reflected in the recorded data
Optionally the digital signatures of CIDP patients will be compared to these of healthy controls wearing the smartwatch
Patients were recruited in Düsseldorf and Münster
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