CIDPEMDA CIDPNCT05723848
Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
An observational study of CIDP, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIDP
- What is being tested?
- Smartwatch (Withings Scanwatch)
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Jan 2023to 16 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CIDP patients with ongoing standard of care IVIG treatment, older or 18 years
Who may be able to join
- 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.
Who cannot join
- unable to use smartwatch or/and smartphone device
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medical Faculty, Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
University Hospital Münster, Department of Neurology
Münster, North Rhine-Westphalia, 48149
About this study
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.
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.
Read the 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
- Being tested
- Smartwatch (Withings Scanwatch)
- 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
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Polyneuropathies, Peripheral Nervous System Diseases, Neuromuscular Diseases, Nervous System Diseases, Polyradiculoneuropathy, Autoimmune Diseases of the Nervous System, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch (Withings Scanwatch)Device
All-day monitoring of patients via smartwatch
| Study group | Role | What they receive |
|---|---|---|
| CIDP patients | CIDP patients with ongoing standard of care IVIG treatment Receives: Device: Smartwatch (Withings Scanwatch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Grip strength
Measured: 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
Measured: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Subjective occurrence of end-of-dose phenomena/wearing off
Measured: 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
Measured: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Pittsburgh Sleep Quality Index (PSQI)
Measured: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Blood analysis (levels of sNfl, serum proteomics)
Measured: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Questionnaire about smartwatch usage
Measured: After 6 months (V3)
Wearing time of smartwatch (daily)
Measured: 180 days
Longitudinal development of activity parameter: step count
Measured: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Measured: 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
Measured: 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
Measured: 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
Measured: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Measured: 180 days
Longitudinal development of activity parameter: approximate calories burned
Measured: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Measured: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Measured: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Measured: 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)
Measured: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Jan 2023
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CIDPStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Marc Günter Pawlitzki, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723848
- Sponsor's protocol ID
- 2022-1881
- Acronym
- EMDA CIDP
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37612774
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05723848
- Acronym / sponsor ID
- EMDA CIDP / 2022-1881
- Conditions
- CIDP
- Keywords
- Smartwatch, end of dose phenomenon, neuropathy, Polyneuropathies, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Peripheral Nervous System Diseases, Neuromuscular Diseases, Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIDP patients | – | Device: Smartwatch (Withings Scanwatch)CIDP patients with ongoing standard of care IVIG treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CIDP patients with ongoing standard of care IVIG treatment, older or 18 years
Key inclusion criteria (4 listed)
- IVIG treated ? (all criteria a-c must be met):
Key exclusion criteria (1 listed)
- unable to use smartwatch or/and smartphone device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch (Withings Scanwatch)All-day monitoring of patients via smartwatch | Device | CIDP patients |
Primary outcome
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
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
Change in Grip strength
Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
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
Change in Subjective occurrence of end-of-dose phenomena/wearing off
Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
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
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Blood analysis (levels of sNfl, serum proteomics)
Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Questionnaire about smartwatch usage
Time frame: After 6 months (V3)
Wearing time of smartwatch (daily)
Time frame: 180 days
Longitudinal development of activity parameter: step count
Time frame: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 180 days
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
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
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
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 180 days
Longitudinal development of activity parameter: approximate calories burned
Time frame: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Time frame: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 180 days
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)
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 180 days
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.
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.
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.
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.
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Derived from this study: PubMed 37612774Masanneck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) (time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.