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Behavioural Intervention

Intermittent Hypoxia for Multiple Sclerosis

N/A

Recruiting

Led By Milap Sandhu, Pt, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapse free for at least 1 year

Motor Functional System Scale (FSS) between 2-4

Must not have

Chronic obstructive pulmonary disease

Uncontrolled Sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and following each 5-day intervention block

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study a new treatment for people with multiple sclerosis (MS) involving breathing low levels of oxygen for short periods. This treatment is called Acute Intermittent Hypoxia (

Who is the study for?

This trial is for people with multiple sclerosis (MS) who are interested in a novel intervention that involves breathing low levels of oxygen intermittently, similar to the air on a tall mountain. The study will explore how this affects brain activation and ankle strength.

What is being tested?

The study is testing Acute Intermittent Hypoxia (AIH), where participants breathe short bursts of low-oxygen air. It compares AIH's effects on brain function and muscle strength against a sham procedure (a fake treatment that mimics AIH without using actual low oxygen).

What are the potential side effects?

While not explicitly listed, side effects may include discomfort from breathing low levels of oxygen such as dizziness or lightheadedness, similar to what might be experienced at high altitudes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been free from cancer relapse for at least 1 year.

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My motor function is moderately impaired.

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My disability level is moderate to severe but I can still walk.

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I am between 18 and 75 years old.

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I have been diagnosed with a relapsing form of multiple sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic obstructive pulmonary disease.

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I have sleep apnea that is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and following each 5-day intervention block

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and following each 5-day intervention block

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and following each 5-day intervention block for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ankle Plantarflexion Strength

Secondary study objectives

Task fMRI

Other study objectives

12-Item Multiple Sclerosis walk scale (MSWS-12)

Resting-State fMRI

Six-Minute Walk test

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham FirstExperimental Treatment2 Interventions

Participants in the Sham First arm will undergo 5 days of Sham-Acute Intermittent Hypoxia Interventions. Following the 5 Days of Sham-AIH, after a 2-week washout period, this group will then undergo 5 days of AIH Interventions. The procedures are identical to Sham-AIH but with 9-10% oxygen for the first breath cycle

Group II: AIH FirstExperimental Treatment2 Interventions

Participants in the AIH First arm will undergo 5 days of Acute Intermittent Hypoxia Interventions. Following the 5 Days of AIH, after a 2-week washout period, this group will then undergo 5 days of Sham AIH Interventions. The procedures are identical to AIH but with 21% oxygen for both breath cycles

0 / 7Eligibility criteria met