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| ID | Type | Description | Link |
|---|---|---|---|
| LOxyMS USASK -0924 | Other Identifier | University of Saskatchewan |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Acute Intermittent Hypoxia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 < 78%, Heart rate < 50 beats per minute (bpm) or > 160 bpm | Number of episodes of each outcome | During the six AIH treatment session in weeks 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the six AIH treatment sessions in weeks 1-4 |
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Inclusion Criteria:
-
Group 1:
Group 2:
Group 3:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine B Knox, MD, FRPC | Contact | 306-655-7742 | Katherine.knox@saskatoonhealthregion.ca | |
| Sarah Donkers, PhD | Contact | 306-966-3230 | sarah.donkers@usask.ca |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Pilot interventional study where the investigational drug product is 10% oxygen delivered intermittently. (No Objection Letter File # from Health Canada HC6-024-c292683)
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| Functional testing 1: Nine-Hole Peg test | A test of hand function and dexterity | Baseline, 1- and 5- weeks after the final AIH treatment session |
| Functional testing 2: Symbol Digit Modalities Test | A cognitive test of processing speed | Baseline, 1- and 5- weeks after the final AIH treatment session |
| Functional testing 3: Timed 25-Foot walk test | A test of gait | 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 | 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 | 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. | Baseline, 1- and 5- weeks after the final AIH treatment session |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |