Intermittent Hypoxia Intervention in MS Patients

Study Overview
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Brief Summary
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This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.

Official Title
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Safety and Tolerance of an Intermittent Intervention in MS Patients

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years confirmed MS (all types of MS) ability to come to the outpatient clinic 2-3x/week for 3 months EDSS ≤ 6.5 inconspicuous medical examination inconspicuous ECG Exclusion Criteria: relapse in the last 3 months EDSS progression in the last 6 months pregnancy contraindication for MRI severe heart disease severe asthma, COPD cancer severe cognitive deficits chronic headache renal insufficiency anaemia (Hb < 10 g/dl) insulin-dependent diabetes mellitus severe vascular stenosis former episodes of severe high mountain sickness cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 43 Mild Fatigue 53 Medium Fatigue 63 Severe Fatigue | 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) |