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NCT Number: NCT07631143

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

AIH is a treatment where people breathe reduced amounts of oxygen (10% oxygen) for a short period of time alternating with normal oxygen levels (21%) through a facemask that is attached to an oxygen tank with 10% 02. Participants will undergo 6 AIH treatment sessions over 3-4 weeks.

AIH will be administered to 3 unique groups of people: 1) People with advanced MS disability who are no longer ambulatory, 2) People who experienced a disabling relapse within the past 4 weeks and 3) People with non-active, progressive MS who retain some ambulatory ability.

There will be one baseline and two post-treatment assessments (1 and 5 weeks following the last AIH session).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Intermittent Hypoxia

Other

Hypoxia (10% O2) will be administered via a non-rebreather face mask connected to an oxygen tank supplying the 10% O2. Each session will involve 15 cycles of hypoxia, each lasting 90 seconds, interspersed with 60 second cycles of normoxia. The total duration of each session will be approximately 37 minutes. An inline oxygen analyzer will allow recording of the percentage of oxygen being delivered. A fingertip pulse-oximeter will be worn throughout to ensure that oxygen saturation (SpO2) falls to a nadir between 80 - 87% during hypoxic episodes and heart rate monitoring will be performed. Blood pressure will be checked prior to and following each session (within 5 minutes of treatment cessation).

Primary outcomes

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

    Time frame: During the six AIH treatment session in weeks 1-4

    Number of episodes of each outcome

Secondary outcomes

  1. Worsening on a verbal response 9-Item subjective symptom checklist

    Time frame: During the six AIH treatment sessions in weeks 1-4

    Symptom checklist to be administered during AIH treatments. Includes the following: Chest pain, shortness of breath, lightheadedness, neck pain, dizziness, arm pain (left side for cardiac symptoms), sweatiness/feeling warm, sensory changes and increased weakness.

  2. Functional testing 1: Nine-Hole Peg test

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

    A test of hand function and dexterity

  3. Functional testing 2: Symbol Digit Modalities Test

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

    A cognitive test of processing speed

  4. Functional testing 3: Timed 25-Foot walk test

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

    A test of gait

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

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

    An assessment of how MS impacts a person's function

  6. Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale

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

    An assessment of how fatigue impacts a person's function

  7. Transcranial Magnetic Stimulation (TMS)

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

    TMS uses a magnetic coil placed over the scalp to stimulate cortical neurons on the surface of the brain to elicit a motor evoked potential (MEP). The amount of stimulator output required to obtain a MEP is an indicator of the level of excitability of the neurons; lower threshold indicating greater excitability AIH may decrease inhibition and increase excitation; mechanisms necessary when recovering from neurological injuries.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine B Knox, MD, FRPC

CONTACT

[email protected]

306-655-7742

Sarah Donkers, PhD

CONTACT

[email protected]

306-966-3230

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Acronym: LOxyMS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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