Multiple SclerosisPhase 1/2LOxyMSNCT07631143
Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With MS
A Phase 1/2 study testing Acute Intermittent Hypoxia in people with Multiple Sclerosis, run by University of Saskatchewan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Acute Intermittent Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With Multiple Sclerosis
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.
Read the detailed description
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).
- Conditions
- Multiple Sclerosis
- Being tested
- Acute Intermittent Hypoxia
- Keywords
- Acute Intermittent Hypoxia
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent HypoxiaOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Acute Intermittent Hypoxia Receives: Other: Acute Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm
Number of episodes of each outcome
Measured: During the six AIH treatment session in weeks 1-4
Secondary outcomes (7)
Worsening on a verbal response 9-Item subjective symptom checklist
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.
Measured: During the six AIH treatment sessions in weeks 1-4
Functional testing 1: Nine-Hole Peg test
A test of hand function and dexterity
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 2: Symbol Digit Modalities Test
A cognitive test of processing speed
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 3: Timed 25-Foot walk test
A test of gait
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29)
An assessment of how MS impacts a person's function
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale
An assessment of how fatigue impacts a person's function
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Transcranial Magnetic Stimulation (TMS)
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.
Measured: Baseline, 1- and 5- weeks after the final AIH treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot interventional study where the investigational drug product is 10% oxygen delivered intermittently. (No Objection Letter File # from Health Canada HC6-024-c292683)
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Knox, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631143
- Sponsor's protocol ID
- Bio 4476
- Other IDs
- LOxyMS USASK -0924
- Acronym
- LOxyMS
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Low Oxygen Breathing: A First Study Testing Different Disease Stages in People Living With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07631143
- Acronym / sponsor ID
- LOxyMS / Bio 4476
- Conditions
- Multiple Sclerosis
- Keywords
- Acute Intermittent Hypoxia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot interventional study where the investigational drug product is 10% oxygen delivered intermittently. (No Objection Letter File # from Health Canada HC6-024-c292683)
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Acute Intermittent HypoxiaAcute Intermittent Hypoxia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- 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
- People with a confirmed diagnosis of relapsing remitting MS
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent HypoxiaHypoxia (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). | Other | Treatment |
Primary outcome
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
7 secondary outcomes
Worsening on a verbal response 9-Item subjective symptom checklist
Time frame: During the six AIH treatment sessions in weeks 1-4
Functional testing 1: Nine-Hole Peg test
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 2: Symbol Digit Modalities Test
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 3: Timed 25-Foot walk test
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Patient Reported Symptom Outcomes 1: Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Patient Reported Symptom Outcomes 2: Modified Fatigue Impact Scale
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Transcranial Magnetic Stimulation (TMS)
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acute Intermittent Hypoxia in people with Multiple Sclerosis, run by University of Saskatchewan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine B Knox, MD, FRPC (306-655-7742, Katherine.knox@saskatoonhealthregion.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm (time frame: During the six AIH treatment session in weeks 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.