Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Shirley Ryan AbilityLab
- Study ID
- NCT06390930
- Status
- Recruiting
Conditions
- Multiple Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Multiple Sclerosis, Secondary Progressive
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Acute Intermittent Hypoxia — OTHERDuring AIH, 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 cycle involves breathing air with lower oxygen concentration (9-10% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.
- Sham Acute Intermittent Hypoxia — OTHERDuring Sham AIH, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The Sham AIH intervention involves alternating breathing cycles. One cycle involves breathing air closely resembling room air (\~21% oxygen) for 30 and 90 seconds, followed by breathing normal room air (21% oxygen) for a similar duration. This cycle is repeated 15 times in one session. Blood oxygen and heart rate are monitored throughout.
Study Details
This study seeks to explore changes in the neural pathways and arm function following a breathing intervention in the multiple sclerosis (MS) population. The breathing intervention, known as Acute Intermittent Hypoxia (AIH), involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. Here, the study examines arm and hand function before and after AIH. In order to better understand the brain and spinal cord response to AIH, the investigators will measure muscle response, and signals sent from the brain to the arm muscles before and after AIH.
Key Dates
- Start date
- Feb 1, 2025
- Status verified
- Feb 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 22 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: AIH firstParticipants in the first arm will undergo 2 sessions of AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of Sham AIH also separated by a 1-week washout period.
- Experimental: Sham FirstParticipants in the this arm will undergo 2 sessions of Sham AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of AIH also separated by a 1-week washout period.
Primary Outcome Measure
Motor Evoked Potentials (MEPs) in First Dorsal Interosseous (FDI) [ Time Frame: Immediately before, immediately after, and 60 minutes after the intervention. ]
Central Contacts
- Rachel Kalvakota, OTD, OTR/L3122383947
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | Milap Sandhu, PT, PhD (PRINCIPAL_INVESTIGATOR) |
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