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This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | 2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Lake Louise Score (LLS) | Tolerance by measuring the development of acute mountain sickness during the sessions Score 3 to 5 = mild AMS Score 6 or more = severe AMS | Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Timed 25-Foot Walk (T25-FW) |
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Inclusion Criteria:
Exclusion Criteria:
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MS patients with all types of MS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf, INIMS | Hamburg | Germany |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Blood
Quantitative mobility and leg function performance test based on a timed 25-walk |
| Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| 6 minute walking test (6MWT) | Maximum distance in 6 minutes | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| 9-Hole-Peg-Test (9 HPT) | Quantitative test of upper extremity function | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Verbal learning and memory test (VLMT) | Rapid and delayed recall | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Symbol Digit Modalities Test (SDMT) | Test for concentration and decision making | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Brief Visuospatial Memory Test-Revised (BVMT-R) | Test for visuospatial memory | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Frenchay Activities Index (FAI) | Measure of instrumental activities of daily living (IADL) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Fatigue Scale Motor Cognition (FSMC) | Measure MS-related cognitive and motor fatigue in MS
| Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Beck Depression Inventory (BDI) | Measure severity of depression | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| MRI Lesions | T2 and Gd enhancing T1 lesions | Baseline, at the end of the intervention (after 3 months) |
| Brain atrophy | MRI | Baseline, at the end of the intervention (after 3 months) |
| Immune cell subsets | FACS analysis | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Heart rate | bpm by pulsoxymeter | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Blood pressure | mmHg | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Heart rate | bpm by pulsoxymeter | During every session (2hours/session) |
| Oxygen saturation | measured by pulsoxymeter | During every session (2hours/session) |
| Blood sugar | mg/dl in the blood sample | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Blood count | Hb, Hct, Leucocytes, Lymphocytes, Thrombocytes, Neutrophils in th blood sample | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Erythropoetin | blood sample | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Liver enzymes | GOT, GPT, GGT (blood sample) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| Kidney enzyme | Creatinine (blood sample) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| NFL | Neurofilament light chain (serum) | Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |