Intermittent Hypoxia in Persons With Multiple Sclerosis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06276634
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Mar 2026
Primary completion
Nov 3, 2025
Completion
Jan 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Alexander Barry, MS, CCRC
[email protected]
3122381435
Milap Sandhu, PT, PhD (PRINCIPAL_INVESTIGATOR)
Molly Bright, D.Phil. (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Multiple sclerosis
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NeurologyBrain disordersAutoimmune disease
By research site
Shirley Ryan AbilityLab· Chicago, IL

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