Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04635033
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intermittent Hypoxia Intervention in MS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lake Louise Score (LLS)', 'timeFrame': 'Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session', 'description': 'Tolerance by measuring the development of acute mountain sickness during the sessions Score 3 to 5 = mild AMS Score 6 or more = severe AMS'}], 'secondaryOutcomes': [{'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS)'}, {'measure': 'Timed 25-Foot Walk (T25-FW)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Quantitative mobility and leg function performance test based on a timed 25-walk'}, {'measure': '6 minute walking test (6MWT)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Maximum distance in 6 minutes'}, {'measure': '9-Hole-Peg-Test (9 HPT)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Quantitative test of upper extremity function'}, {'measure': 'Verbal learning and memory test (VLMT)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Rapid and delayed recall'}, {'measure': 'Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Test for concentration and decision making'}, {'measure': 'Brief Visuospatial Memory Test-Revised (BVMT-R)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Test for visuospatial memory'}, {'measure': 'Frenchay Activities Index (FAI)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Measure of instrumental activities of daily living (IADL)'}, {'measure': 'Fatigue Scale Motor Cognition (FSMC)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Measure MS-related cognitive and motor fatigue in MS\n\n* 43 Mild Fatigue\n* 53 Medium Fatigue\n* 63 Severe Fatigue'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Measure severity of depression'}, {'measure': 'MRI Lesions', 'timeFrame': 'Baseline, at the end of the intervention (after 3 months)', 'description': 'T2 and Gd enhancing T1 lesions'}, {'measure': 'Brain atrophy', 'timeFrame': 'Baseline, at the end of the intervention (after 3 months)', 'description': 'MRI'}, {'measure': 'Immune cell subsets', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'FACS analysis'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'bpm by pulsoxymeter'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'During every session (2hours/session)', 'description': 'bpm by pulsoxymeter'}, {'measure': 'Oxygen saturation', 'timeFrame': 'During every session (2hours/session)', 'description': 'measured by pulsoxymeter'}, {'measure': 'Blood sugar', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'mg/dl in the blood sample'}, {'measure': 'Blood count', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Hb, Hct, Leucocytes, Lymphocytes, Thrombocytes, Neutrophils in th blood sample'}, {'measure': 'Erythropoetin', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'blood sample'}, {'measure': 'Liver enzymes', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'GOT, GPT, GGT (blood sample)'}, {'measure': 'Kidney enzyme', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Creatinine (blood sample)'}, {'measure': 'NFL', 'timeFrame': 'Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)', 'description': 'Neurofilament light chain (serum)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MS patients with all types of MS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years\n* confirmed MS (all types of MS)\n* ability to come to the outpatient clinic 2-3x/week for 3 months\n* EDSS ≤ 6.5\n* inconspicuous medical examination\n* inconspicuous ECG\n\nExclusion Criteria:\n\n* relapse in the last 3 months\n* EDSS progression in the last 6 months\n* pregnancy\n* contraindication for MRI\n* severe heart disease\n* severe asthma, COPD\n* cancer\n* severe cognitive deficits\n* chronic headache\n* renal insufficiency\n* anaemia (Hb \\< 10 g/dl)\n* insulin-dependent diabetes mellitus\n* severe vascular stenosis\n* former episodes of severe high mountain sickness\n* cancer'}, 'identificationModule': {'nctId': 'NCT04635033', 'acronym': 'MSHYPE', 'briefTitle': 'Intermittent Hypoxia Intervention in MS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Safety and Tolerance of an Intermittent Intervention in MS Patients', 'orgStudyIdInfo': {'id': 'MS HYPE Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': '2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf, INIMS', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. med. Christoph Heesen', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}