Intermittent Hypoxia Intervention in MS Patients

Multiple Sclerosis Clinical Trial

— MSHYPE  

Official title:

Safety and Tolerance of an Intermittent Intervention in MS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635033
• Other study ID #: MS HYPE Pilot
• Status: Completed
• Start date: September 19, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: November 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf, INIMS	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Beck Depression Inventory (BDI)	Measure severity of depression	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	MRI Lesions	T2 and Gd enhancing T1 lesions	Baseline, at the end of the intervention (after 3 months)
Secondary	Brain atrophy	MRI	Baseline, at the end of the intervention (after 3 months)
Secondary	Immune cell subsets	FACS analysis	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	Heart rate	bpm by pulsoxymeter	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	Blood pressure	mmHg	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	Heart rate	bpm by pulsoxymeter	During every session (2hours/session)
Secondary	Oxygen saturation	measured by pulsoxymeter	During every session (2hours/session)
Secondary	Blood sugar	mg/dl in the blood sample	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	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)
Secondary	Erythropoetin	blood sample	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	Liver enzymes	GOT, GPT, GGT (blood sample)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	Kidney enzyme	Creatinine (blood sample)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Secondary	NFL	Neurofilament light chain (serum)	Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)