Intermittent Hypoxia Intervention in MS Patients

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04635033
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Study First Submitted: 2020-10-22
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lake Louise Score (LLS)	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 Outcome Measures

Name	Time	Method
Immune cell subsets	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	FACS analysis
Kidney enzyme	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Creatinine (blood sample)
Brain atrophy	Baseline, at the end of the intervention (after 3 months)	MRI
Timed 25-Foot Walk (T25-FW)	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
MRI Lesions	Baseline, at the end of the intervention (after 3 months)	T2 and Gd enhancing T1 lesions
Blood pressure	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	mmHg
Erythropoetin	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	blood sample
6 minute walking test (6MWT)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Maximum distance in 6 minutes
Blood count	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
Liver enzymes	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	GOT, GPT, GGT (blood sample)
NFL	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Neurofilament light chain (serum)
Expanded Disability Status Scale (EDSS)	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)
Symbol Digit Modalities Test (SDMT)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Test for concentration and decision making
Brief Visuospatial Memory Test-Revised (BVMT-R)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Test for visuospatial memory
9-Hole-Peg-Test (9 HPT)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Quantitative test of upper extremity function
Frenchay Activities Index (FAI)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Measure of instrumental activities of daily living (IADL)
Beck Depression Inventory (BDI)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Measure severity of depression
Verbal learning and memory test (VLMT)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	Rapid and delayed recall
Fatigue Scale Motor Cognition (FSMC)	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
Heart rate	During every session (2hours/session)	bpm by pulsoxymeter
Oxygen saturation	During every session (2hours/session)	measured by pulsoxymeter
Blood sugar	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)	mg/dl in the blood sample

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf, INIMS; 🇩🇪 Hamburg, Germany