Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634 | Recruiting

• 2 other identifiers: STU00219535R21HD108587
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis-Relapsing-Remitting; Multiple Sclerosis

Keywords

multiple sclerosis; AIH; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Ankle Plantarflexion Strength

  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

  Before and following each 5-day intervention block

Secondary Outcomes (1)

• Task fMRI

  Before and following each 5-day intervention block

Other Outcomes (5)

• Timed 25 Feet Walk test

  Before and following each 5-day intervention block

• Six-Minute Walk test

  Before and following each 5-day intervention block

• Stride length

  Before and following each 5-day intervention block

Study Arms (2)

AIH First

EXPERIMENTAL

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

Other: Acute Intermittent Hypoxia; Other: Sham-Acute Intermittent Hypoxia

Sham First

EXPERIMENTAL

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

Other: Acute Intermittent Hypoxia; Other: Sham-Acute Intermittent Hypoxia

Interventions

Acute Intermittent Hypoxia OTHER

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.

Also known as: AIH

AIH First; Sham First

Sham-Acute Intermittent Hypoxia OTHER

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.

AIH First; Sham First

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Northwestern University: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Hypoxia

Interventions

Insemination, Artificial, Homologous

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Milap Sandhu, Pt, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Barry, MS, CCRC

CONTACT

3122381435; abarry@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 26, 2024
• Study Start: April 30, 2024
• Primary Completion: November 3, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)