Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT07273903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)', 'description': '24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points'}, {'measure': 'Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)', 'description': 'minimum value: 0 points, maximum value: 10 points, best result: 0 points'}, {'measure': 'Longitudinal development of activity parameter: step count', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings', 'timeFrame': '365 days', 'description': 'Examples for moderate activity:\n\nWalking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening'}], 'secondaryOutcomes': [{'measure': 'Change in Grip strength', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)', 'description': 'Measured via Vigorimeter in kPa'}, {'measure': 'Change in Medical Research Council (MRC)-Sumscore', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)', 'description': 'minimum value: 0 points, maximum value: 60 points, best result: 60 points'}, {'measure': 'Longitudinal development of activity parameter: approximate distance traveled (meter)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings', 'timeFrame': '365 days', 'description': 'Examples for soft activity:\n\nSleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes'}, {'measure': 'Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings', 'timeFrame': '365 days', 'description': 'Examples for intense activity:\n\nHiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope'}, {'measure': 'Longitudinal development of activity parameter: sum of all active time (seconds)', 'timeFrame': '365 days'}, {'measure': 'Wearing time of smartwatch (daily)', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)'}, {'measure': 'Longitudinal development of activity parameter: approximate calories burned', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)'}, {'measure': 'Change in Subjective occurrence of end-of-dose phenomena/wearing off', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)'}, {'measure': 'Change in Quality of life (QoL)', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)', 'description': "The Quality of Life Questionnaire (QoL) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas, WHOQOL-BREF (World Health Organization Quality of Life - abbreviated version)"}, {'measure': 'Change in Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)'}, {'measure': 'Change in Blood analysis (levels of sNfl, serum proteomics)', 'timeFrame': 'Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)'}, {'measure': 'Questionnaire about smartwatch usage', 'timeFrame': 'End of study visit (after 12 months, V5)'}, {'measure': 'Longitudinal development of sleep parameter: time awake (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: number of times user woke up', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: time to sleep (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: total time in bed (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: total time asleep (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: WASO', 'timeFrame': '365 days', 'description': 'Wake after sleep onset (WASO): total time asleep divided by total time in bed'}, {'measure': 'Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of sleep parameter: Withings Sleep score', 'timeFrame': '365 days', 'description': "Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs:\n\n* Duration (total time spent sleeping)\n* Depth (part of night spent in restorative phases and deep sleep)\n* Regularity (consistency between your bed- and rise-times)\n* Interruptions (time spent awake)"}, {'measure': 'Longitudinal development of cardiovascular parameter: average heartrate', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of cardiovascular parameter: maximal heartrate', 'timeFrame': '365 days'}, {'measure': 'Longitudinal development of cardiovascular parameter: minimum heartrate', 'timeFrame': '365'}, {'measure': 'Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)', 'timeFrame': '365 days', 'description': 'Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.'}, {'measure': 'Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)', 'timeFrame': '365 days', 'description': 'Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.'}, {'measure': 'Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)', 'timeFrame': '365 days', 'description': 'Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.'}, {'measure': 'Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)', 'timeFrame': '365 days', 'description': 'Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate.'}, {'measure': 'Number and time of Irregular 1-channel ECGs (according to Withings algorithm)', 'timeFrame': '365 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CIDP', 'IVIG', 'SCIG', 'wearable', 'steps', 'sleep', 'DHT'], 'conditions': ['CIDP - Chronic Inflammatory Demyelinating Polyneuropathy']}, 'referencesModule': {'references': [{'pmid': '40635238', 'type': 'BACKGROUND', 'citation': 'Masanneck L, Voth J, Gmahl N, Jendretzky K, Huntemann N, Werner NM, Schmidt L, Oeztuerk M, Quint P, Schroeter CB, Hartung HP, Skripuletz T, Meyer Zu Horste G, Ruck T, Meuth SG, Pawlitzki M. Digital Activity Markers in Chronic Inflammatory Demyelinating Polyneuropathy. Ann Clin Transl Neurol. 2025 Oct;12(10):2045-2055. doi: 10.1002/acn3.70137. Epub 2025 Jul 9.'}]}, 'descriptionModule': {'briefSummary': "Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).\n\nThe S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.\n\nStudy Goals:\n\nThe main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).\n\nSecondary goals include:\n\nAssessing how smartwatch data relate to patients' quality of life and sleep patterns.\n\nComparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.\n\nEvaluating how well patients can use the smartwatch over the long term during home treatment.\n\nAn additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.\n\nStudy Design:\n\nThis is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.\n\nParticipants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.\n\nDuration:\n\nRecruitment will last about 6 months, and each participant will be followed for 12 months.\n\nWhy This Matters:\n\nBy combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CIDP adult patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), switched from IVIG to fSCIG within 6 months or during recruitment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed typical or possible typical CIDP according to the 2021 EAN/PNS criteria\n* Age ≥18 years\n* Ability to use a smartwatch as decided by the investigator\n* switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase\n* on investigator-confirmed stable IVIG therapy pre-switch\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Inability to operate smartwatch or smartphone device\n* current pregnancy and breastfeeding status\n* CIDP variants according to the 2021 EAN/PNS criteria'}, 'identificationModule': {'nctId': 'NCT07273903', 'acronym': 'STEPS', 'briefTitle': 'Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices', 'orgStudyIdInfo': {'id': 'STEPS_1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIDP patients', 'description': 'CIDP patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), Switched from IVIG to fSCIG within 6 months or during recruitment, Must be able to use smartwatch + smartphone, Exclude: CIDP variants, pregnancy, breastfeeding, inability to use devices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'contacts': [{'name': 'Marc G Pawlitzki, PD Dr. med.', 'role': 'CONTACT', 'email': 'neuro-trials@med.uni-duesseldorf.de', 'phone': '+49 02118117887'}], 'facility': 'University Hospital Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'contacts': [{'name': 'Matthias Schilling, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'matthias.schilling@-ukmuenster.-de', 'phone': '+49 251 83-48199'}], 'facility': 'University Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Marc G Pawlitzki, PD Dr. med.', 'role': 'CONTACT', 'email': 'neuro-trials@med.uni-duesseldorf.de', 'phone': '+49 02118117887'}], 'overallOfficials': [{'name': 'Marc G Pawlitzki, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study coordinator / PI', 'investigatorFullName': 'Dr. med. Marc Günter Pawlitzki', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}