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Completed

NCT Number: NCT04635033

Intermittent Hypoxia Intervention in MS Patients

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf, INIMS

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    MS impairment measurement with a score ranging from 0.0 (normal neurological exam) to 10.0 (death due to MS)

  2. Timed 25-Foot Walk (T25-FW)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Quantitative mobility and leg function performance test based on a timed 25-walk

  3. 6 minute walking test (6MWT)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Maximum distance in 6 minutes

  4. 9-Hole-Peg-Test (9 HPT)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Quantitative test of upper extremity function

  5. Verbal learning and memory test (VLMT)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Rapid and delayed recall

  6. Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Test for concentration and decision making

  7. 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)

    Test for visuospatial memory

  8. Frenchay Activities Index (FAI)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Measure of instrumental activities of daily living (IADL)

  9. Fatigue Scale Motor Cognition (FSMC)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Measure MS-related cognitive and motor fatigue in MS

    • 43 Mild Fatigue
    • 53 Medium Fatigue
    • 63 Severe Fatigue

  10. Beck Depression Inventory (BDI)

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Measure severity of depression

  11. MRI Lesions

    Time frame: Baseline, at the end of the intervention (after 3 months)

    T2 and Gd enhancing T1 lesions

  12. Brain atrophy

    Time frame: Baseline, at the end of the intervention (after 3 months)

    MRI

  13. Immune cell subsets

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    FACS analysis

  14. Heart rate

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    bpm by pulsoxymeter

  15. Blood pressure

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    mmHg

  16. Heart rate

    Time frame: During every session (2hours/session)

    bpm by pulsoxymeter

  17. Oxygen saturation

    Time frame: During every session (2hours/session)

    measured by pulsoxymeter

  18. Blood sugar

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    mg/dl in the blood sample

  19. Blood count

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Hb, Hct, Leucocytes, Lymphocytes, Thrombocytes, Neutrophils in th blood sample

  20. Erythropoetin

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    blood sample

  21. Liver enzymes

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    GOT, GPT, GGT (blood sample)

  22. Kidney enzyme

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Creatinine (blood sample)

  23. NFL

    Time frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

    Neurofilament light chain (serum)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Safety and Tolerance of an Intermittent Intervention in MS Patients

Acronym: MSHYPE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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