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NCT Number: NCT05723848

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

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.

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Key information

Conditions

CIDP Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Faculty, Heinrich-Heine-University, Düsseldorf, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IVIG treated ? (all criteria a-c must be met):
  • Documented evidence of objective response to IVIG, with clinically meaningful improvement. Clinically meaningful improvement is defined as one of the following: ≥1-point decrease in adjusted INCAT score, ≥4 points increase in I-RODS total score, ≥3 points increase in MRC Sum score, ≥8 kilopascal improvement in mean grip strength (one hand), or an equivalent improvement based on information documented in medical records and per the PI's judgement.
  • Must be on stable IVIG therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or corticosteroids within 8 weeks prior to screening
  • Evidence of clinically meaningful deterioration on interruption or dose reduction of IVIG therapy within 24 months prior to screening, determined by clinical examination or medical records. Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in I-RODS total score ≥4 points, decrease in MRC Sum score ≥3, mean grip strength worsening of ≥8 kilopascals (one hand), or an equivalent deterioration based on information from medical records and at the PI's judgement.

Exclusion criteria

  • unable to use smartwatch or/and smartphone device

Treatment and study plan

Smartwatch (Withings Scanwatch)

Device

All-day monitoring of patients via smartwatch

Primary outcomes

  1. Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

    24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points

  2. Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

    minimum value: 0 points, maximum value: 10 points, best result: 0 points

  3. Change in Grip strength

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

  4. Change in Medical Research Council (MRC)-Sumscore

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

    minimum value: 0 points, maximum value: 60 points, best result: 60 points

  5. Change in Subjective occurrence of end-of-dose phenomena/wearing off

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

  6. Change in Quality of life (QoL)

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

    The Quality of Life Questionnaire (QoL) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas

  7. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

  8. Change in Blood analysis (levels of sNfl, serum proteomics)

    Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)

  9. Questionnaire about smartwatch usage

    Time frame: After 6 months (V3)

  10. Wearing time of smartwatch (daily)

    Time frame: 180 days

  11. Longitudinal development of activity parameter: step count

    Time frame: 180 days

  12. Longitudinal development of activity parameter: approximate distance traveled (meter)

    Time frame: 180 days

  13. Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings

    Time frame: 180 days

    Examples for soft activity:

    Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes

  14. Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings

    Time frame: 180 days

    Examples for moderate activity:

    Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening

  15. Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings

    Time frame: 180 days

    Examples for intense activity:

    Hiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope

  16. Longitudinal development of activity parameter: sum of all active time (seconds)

    Time frame: 180 days

  17. Longitudinal development of activity parameter: approximate calories burned

    Time frame: 180 days

  18. Longitudinal development of sleep parameter: time awake (seconds)

    Time frame: 180 days

  19. Longitudinal development of sleep parameter: number of times user woke up

    Time frame: 180 days

  20. Longitudinal development of sleep parameter: time to sleep (seconds)

    Time frame: 180 days

  21. Longitudinal development of sleep parameter: total time in bed (seconds)

    Time frame: 180 days

  22. Longitudinal development of sleep parameter: total time asleep (seconds)

    Time frame: 180 days

  23. Longitudinal development of sleep parameter: ratio of sleep/time in bed

    Time frame: 180 days

  24. Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)

    Time frame: 180 days

  25. Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)

    Time frame: 180 days

  26. Longitudinal development of sleep parameter: Withings Sleep score

    Time frame: 180 days

    Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs:

    • Duration (total time spent sleeping)
    • Depth (part of night spent in restorative phases and deep sleep)
    • Regularity (consistency between your bed- and rise-times)
    • Interruptions (time spent awake)

  27. Longitudinal development of cardiovascular parameter: average heartrate

    Time frame: 180 days

  28. Longitudinal development of cardiovascular parameter: maximal heartrate

    Time frame: 180 days

  29. Longitudinal development of cardiovascular parameter: minimum heartrate

    Time frame: 180 days

  30. Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)

    Time frame: 180 days

    Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.

  31. Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)

    Time frame: 180 days

    Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.

  32. Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)

    Time frame: 180 days

    Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.

  33. Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)

    Time frame: 180 days

    Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate.

  34. Number and time of Irregular 1-channel ECGs (according to Withings algorithm)

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study 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.

Acronym: EMDA CIDP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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