A Phase 1/2 interventional study of Acute Intermittent Hypoxia in Multiple Sclerosis, sponsored by University of Saskatchewan. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University of Saskatchewan · Phase 1/2, Interventional, and Treatment
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.
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).
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 9 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Group 1:
Group 2:
Group 3:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acute Intermittent Hypoxia
Other: Acute Intermittent Hypoxia
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).
SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm
Number of episodes of each outcome
Time frame: During the six AIH treatment session in weeks 1-4
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.
Time frame: During the six AIH treatment sessions in weeks 1-4
Functional testing 1: Nine-Hole Peg test
A test of hand function and dexterity
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 2: Symbol Digit Modalities Test
A cognitive test of processing speed
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
Functional testing 3: Timed 25-Foot walk test
A test of gait
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, 1- and 5- weeks after the final AIH treatment session
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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