Recruiting

Intermittent Hypoxia

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06276634

Conditions

Multiple Sclerosis

Multiple Sclerosis-Relapsing-Remitting

Multiple Sclerosis, Secondary Progressive

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acute Intermittent Hypoxia

Sham-Acute Intermittent Hypoxia

Study Details

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

Multiple Sclerosis-Relapsing-Remitting

Multiple Sclerosis, Secondary Progressive

Study ID

NCT06276634

Start date

Apr 30, 2024

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Nov 3, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AIH First

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

experimental: Sham First

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

Interventions

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.

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 measure

  • Ankle Plantarflexion Strength [ Time Frame: Before and following each 5-day intervention block ]

Central Contacts and Locations

Central contacts

Alexander Barry, MS, CCRC

3122381435abarry@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Alexander Barry, MS, CCRC

3122381435abarry@sralab.org

Principal Investigator:

Milap Sandhu, PT, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • multiple sclerosis
  • AIH
  • Hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-03-20.