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

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.

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).

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