NCT06276634 · Shirley Ryan AbilityLab
Intermittent Hypoxia in Persons With Multiple Sclerosis
What this study is about
This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time.
View original scientific description
This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.
Interventions
OTHER
Acute Intermittent Hypoxia
During each AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles: one with lower oxygen concentration (9-10% Oxygen) than that at sea level (\~21% Oxygen) lasting between 30 and 60 seconds, followed by a similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.
OTHER
Sham-Acute Intermittent Hypoxia
During each Sham-AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the Sham-AIH intervention. The Sham-AIH intervention involves alternating breathing cycles: both with oxygen concentrations of \~21% Oxygen lasting between 30 and 60 seconds, followed by another similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.
Primary outcome measures
Ankle Plantarflexion Strength
Time frame: Before and following each 5-day intervention block
Participants will be seated in an adjustable chair with tested foot secured to a foot plate with the ankle in line with a rotational load cell. Participants will be asked to produce maximal ankle plantarflexion contractions, Electromyographic signals of the gastrocnemius, tibialis anterior, and soleus will be recorded simultaneously
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)
- Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
- Motor Functional System Scale (FSS) between 2-4
- Relapse free for at least 1 year
- Age ≥ 18 years and ≤ 75 years
- Safe to be scanned based on MRI questionnaire
- Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening
Exclusion criteria
- Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
- Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
- History of epilepsy
- Chronic obstructive pulmonary disease
- Uncontrolled Sleep apnea
Where
- Chicago, Illinois
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northwestern University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations