Intermittent Hypoxia in Persons With Multiple Sclerosis (NCT06276634) | Clinical Trial Compass
RecruitingNot Applicable
Intermittent Hypoxia in Persons With Multiple Sclerosis
United States21 participantsStarted 2024-04-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ankle Plantarflexion Strength
Timeframe: Before and following each 5-day intervention block