Clinical trial NCT04635033: Intermittent Hypoxia Intervention in MS Patients
Official title: Safety and Tolerance of an Intermittent Intervention in MS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS patients with all types of MS

Brief summary: This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.


Eligibility criteria: 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

Primary outcomes:
measure: Lake Louise Score (LLS)
timeFrame: Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Timed 25-Foot Walk (T25-FW)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: 6 minute walking test (6MWT)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: 9-Hole-Peg-Test (9 HPT)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Verbal learning and memory test (VLMT)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
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)
measure: Frenchay Activities Index (FAI)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Fatigue Scale Motor Cognition (FSMC)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: MRI Lesions
timeFrame: Baseline, at the end of the intervention (after 3 months)
measure: Brain atrophy
timeFrame: Baseline, at the end of the intervention (after 3 months)
measure: Immune cell subsets
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Heart rate
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Blood pressure
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Heart rate
timeFrame: During every session (2hours/session)
measure: Oxygen saturation
timeFrame: During every session (2hours/session)
measure: Blood sugar
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Blood count
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Erythropoetin
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Liver enzymes
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: Kidney enzyme
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
measure: NFL
timeFrame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, INIMS
Study officials:
References: