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

NCT05723848 | Completed

• 1 other identifier: 2022-1881
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

CIDP

Keywords

Smartwatch; end of dose phenomenon; neuropathy; Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Outcome Measures

Primary Outcomes (34)

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

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

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

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

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

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

• Change in Grip strength

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

• Change in Medical Research Council (MRC)-Sumscore

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

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

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

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

• Change in Quality of life (QoL)

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

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

• Change in Pittsburgh Sleep Quality Index (PSQI)

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

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

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

• Questionnaire about smartwatch usage

  After 6 months (V3)

• Wearing time of smartwatch (daily)

  180 days

• Longitudinal development of activity parameter: step count

  180 days

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

  180 days

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

  Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes

  180 days

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

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

  180 days

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

  Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope

  180 days

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

  180 days

• Longitudinal development of activity parameter: approximate calories burned

  180 days

• Longitudinal development of sleep parameter: time awake (seconds)

  180 days

• Longitudinal development of sleep parameter: number of times user woke up

  180 days

• Longitudinal development of sleep parameter: time to sleep (seconds)

  180 days

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

  180 days

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

  180 days

• Longitudinal development of sleep parameter: ratio of sleep/time in bed

  180 days

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

  180 days

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

  180 days

• Longitudinal development of sleep parameter: Withings Sleep score

  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)

  180 days

• Longitudinal development of cardiovascular parameter: average heartrate

  180 days

• Longitudinal development of cardiovascular parameter: maximal heartrate

  180 days

• Longitudinal development of cardiovascular parameter: minimum heartrate

  180 days

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

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

  180 days

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

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

  180 days

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

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

  180 days

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

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

  180 days

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

  180 days

Study Arms (1)

CIDP patients

CIDP patients with ongoing standard of care IVIG treatment

Device: Smartwatch (Withings Scanwatch)

Interventions

Smartwatch (Withings Scanwatch) DEVICE

All-day monitoring of patients via smartwatch

CIDP patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CIDP patients with ongoing standard of care IVIG treatment, older or 18 years

You may qualify if:

• 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.

You may not qualify if:

• unable to use smartwatch or/and smartphone device

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (2)

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

University Hospital Münster, Department of Neurology

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

• Masanneck L, Voth J, Huntemann N, Ozturk M, Schroeter CB, Ruck T, Meuth SG, Pawlitzki M. Introducing electronic monitoring of disease activity in patients with chronic inflammatory demyelinating polyneuropathy (EMDA CIDP): trial protocol of a proof of concept study. Neurol Res Pract. 2023 Aug 24;5(1):39. doi: 10.1186/s42466-023-00267-3.

  PMID: 37612774 DERIVED

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Marc Pawlitzki, MD

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 13, 2023
• Study Start: January 20, 2023
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)