Multiple SclerosisMSHYPENCT04635033
Intermittent Hypoxia Intervention in MS Patients
An observational study of Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 19 Sep 2018to 10 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS patients with all types of MS
Who may be able to join
- 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
Who cannot join
- relapse in the last 3 months
- EDSS progression in the last 6 months
- pregnancy
- contraindication for MRI
- severe heart disease
- severe asthma, COPD
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerance of an Intermittent Intervention in MS Patients
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | 2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session
Secondary outcomes (23)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Beck Depression Inventory (BDI)
Measure severity of depression
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
MRI Lesions
T2 and Gd enhancing T1 lesions
Measured: Baseline, at the end of the intervention (after 3 months)
Brain atrophy
MRI
Measured: Baseline, at the end of the intervention (after 3 months)
Immune cell subsets
FACS analysis
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Heart rate
bpm by pulsoxymeter
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Blood pressure
mmHg
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Heart rate
bpm by pulsoxymeter
Measured: During every session (2hours/session)
Oxygen saturation
measured by pulsoxymeter
Measured: During every session (2hours/session)
Blood sugar
mg/dl in the blood sample
Measured: 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
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Erythropoetin
blood sample
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Liver enzymes
GOT, GPT, GGT (blood sample)
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Kidney enzyme
Creatinine (blood sample)
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
NFL
Neurofilament light chain (serum)
Measured: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start19 Sep 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Christoph Heesen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635033
- Sponsor's protocol ID
- MS HYPE Pilot
- Acronym
- MSHYPE
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerance of an Intermittent Intervention in MS Patients
- ClinicalTrials.gov ID
- NCT04635033
- Acronym / sponsor ID
- MSHYPE / MS HYPE Pilot
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | –2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS patients with all types of MS
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- relapse in the last 3 months
- EDSS progression in the last 6 months
- pregnancy
- contraindication for MRI
- severe heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lake Louise Score (LLS)
Time frame: Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session
Tolerance by measuring the development of acute mountain sickness during the sessions Score 3 to 5 = mild AMS Score 6 or more = severe AMS
23 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Timed 25-Foot Walk (T25-FW)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
6 minute walking test (6MWT)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
9-Hole-Peg-Test (9 HPT)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Verbal learning and memory test (VLMT)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Frenchay Activities Index (FAI)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Fatigue Scale Motor Cognition (FSMC)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Beck Depression Inventory (BDI)
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
MRI Lesions
Time frame: Baseline, at the end of the intervention (after 3 months)
Brain atrophy
Time frame: Baseline, at the end of the intervention (after 3 months)
Immune cell subsets
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Heart rate
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Blood pressure
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Heart rate
Time frame: During every session (2hours/session)
Oxygen saturation
Time frame: During every session (2hours/session)
Blood sugar
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Blood count
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Erythropoetin
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Liver enzymes
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Kidney enzyme
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
NFL
Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lake Louise Score (LLS) (time frame: Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.