Intermittent Low Oxygen Breathing: A First Study Testing Different Dis

Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With Multiple Sclerosis

Not yet recruitingPhase 1Phase 2Relapsing and progressiveNCT07631143

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Acute Intermittent Hypoxia

What it measured

Main measures

  • SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm

    During the six AIH treatment session in weeks 1-4

Other measures (7)

  • Worsening on a verbal response 9-Item subjective symptom checklist

    During the six AIH treatment sessions in weeks 1-4

    Pain

  • Functional testing 1: Nine-Hole Peg test

    Baseline, 1- and 5- weeks after the final AIH treatment session

    Arm and hand function

  • Functional testing 2: Symbol Digit Modalities Test

    Baseline, 1- and 5- weeks after the final AIH treatment session

    Thinking and memory

  • Functional testing 3: Timed 25-Foot walk test

    Baseline, 1- and 5- weeks after the final AIH treatment session

    Disability progressionWalking and mobility

  • Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29)

    Baseline, 1- and 5- weeks after the final AIH treatment session

    Quality of life (reported by participants)

  • Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale

    Baseline, 1- and 5- weeks after the final AIH treatment session

    FatigueQuality of life (reported by participants)

  • Transcranial Magnetic Stimulation (TMS)

    Baseline, 1- and 5- weeks after the final AIH treatment session

    Myelin repairNerve conduction tests

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

- Group 1: * People with a confirmed diagnosis of MS and advanced disability level (Expanded Disability Status Scale (EDSS) >6.5 and \<9) * Without relapse for at least 90 days prior * Older than age 18 Group 2: * People with a confirmed diagnosis of relapsing remitting MS * Acute disabling relapse onset within the past 4 weeks. A disabling relapse will be defined as at least 1.0-point increase on the EDSS. * Older than age 18 Group 3: * People with a confirmed diagnosis of MS that is non-active and progressive (Primary or Secondary Progressive MS). Non-active will be defined as without MS relapse, new/enlarging or enhancing MRI lesions within the past 1 year. * EDSS \<=6.5 * Older than age 18

Exclusion criteria

* Pregnancy * Any of the following documented respiratory disorders: obstructive sleep apnea, chronic obstructive pulmonary disease, uncontrolled asthma, hypoxic pulmonary disease, respiratory infection in the previous 3 months * Ischemic cardiac disease * Cardiac arrhythmia * Severe hypertension (>160/100) * Seizure disorders * Medically unstable in another capacity * Unable to provide informed consent

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This study will look at the safety, tolerability and feasibility of a non-invasive treatment called Acute Intermittent Hypoxia (AIH) in people with Multiple Sclerosis (MS) at different stages of the disease course.

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History

    1. Started

      Jul 2026

    2. Main results due

      Aug 2028

    3. Finished

      Aug 2028

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