Intermittent Hypoxia Intervention in MS Patients (MSHYPE)

November 17, 2020 updated by: Prof. Dr. med. Christoph Heesen, Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change of mean LLS before vs. after 1 hour vs. after 2 hours of each session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
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)
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
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)
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
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)
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
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)
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
Test for visuospatial memory
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)
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)
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
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)
Measure severity of depression
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)
T2 and Gd enhancing T1 lesions
Baseline, at the end of the intervention (after 3 months)
Brain atrophy
Time Frame: Baseline, at the end of the intervention (after 3 months)
MRI
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)
FACS analysis
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)
bpm by pulsoxymeter
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)
mmHg
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)
bpm by pulsoxymeter
During every session (2hours/session)
Oxygen saturation
Time Frame: During every session (2hours/session)
measured by pulsoxymeter
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)
mg/dl in the blood sample
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)
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
Time Frame: Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)
blood sample
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)
GOT, GPT, GGT (blood sample)
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)
Creatinine (blood sample)
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)
Neurofilament light chain (serum)
Baseline, 4 weeks after starting the intervention, at the end of the intervention (after 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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