NCT05723848

Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

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
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CIDP

Interventions

Type	Name	Description
DEVICE	Smartwatch (Withings Scanwatch)	All-day monitoring of patients via smartwatch

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2023-02-13
• Last updated: 2024-07-17

Locations

2 sites across 1 country: Germany