Intermittent Hypoxia Intervention in MS Patients
MSHYPE
Safety and Tolerance of an Intermittent Intervention in MS Patients
1 other identifier
observational
12
1 country
1
Brief Summary
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedNovember 18, 2020
November 1, 2020
1.1 years
October 22, 2020
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (23)
Expanded Disability Status Scale (EDSS)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Timed 25-Foot Walk (T25-FW)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
6 minute walking test (6MWT)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
9-Hole-Peg-Test (9 HPT)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Verbal learning and memory test (VLMT)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
- +18 more secondary outcomes
Study Arms (1)
Intervention
2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months
Eligibility Criteria
MS patients with all types of MS
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Hamburg-Eppendorf, INIMS
Hamburg, Germany
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2020
First Posted
November 18, 2020
Study Start
September 19, 2018
Primary Completion
October 10, 2019
Study Completion
October 10, 2019
Last Updated
November 18, 2020
Record last verified: 2020-11