Intermittent Hypoxia Intervention in MS Patients

NCT ID: NCT04635033

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-19

Study Completion Date

2019-10-10

Brief Summary

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

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Christoph Heesen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Hamburg-Eppendorf, INIMS

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MS HYPE Pilot

Identifier Type: -

Identifier Source: org_study_id