Intermittent Hypoxia Intervention in MS Patients (MSHYPE)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf, INIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MS patients with all types of MS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intervention; 2 hours of reduced FiO2 (11-15%) in the inspired air, 2-3x/week, 3 months

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: MS HYPE Pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No