Recruiting

Acute Intermittent Hypoxia

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06390930

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 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.

Conditions

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Multiple Sclerosis, Secondary Progressive

Study ID

NCT06390930

Start date

Feb 1, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of relapsing-remitting MS according to the McDonald criteria, over 5 years ago
  • Relapse free for at least 6 months
  • Expanded Disability Status Scale (EDSS) ≤7
  • Index finger abduction strength <5 according to Medical Research Council Scale, or 9-Hole Peg Test score >20 seconds in at least one hand
  • Stable disease modifying therapies for at least 6 months
  • Individuals taking dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Exclusion Criteria:

  • Another diagnosis (e.g., peripheral neuropathies or orthopedic) affecting upper limb function
  • Mini-Mental State Examination (MMSE) score <24
  • Modified Ashworth Scale score >3 on elbow joint
  • Uncontrolled hypertension or hypotension (outside 140/90 and 85/55 mmHg)
  • History of epilepsy, chronic obstructive pulmonary disease, or sleep apnea
  • Unstable medical conditions, ongoing upper limb therapy, or musculoskeletal pain
  • Pregnancy as confirmed by urine test

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AIH first

Participants 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 First

Participants 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.

Interventions

Acute Intermittent Hypoxia

During 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

During 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.

Primary outcome measure

  • Motor Evoked Potentials (MEPs) in First Dorsal Interosseous (FDI) [ Time Frame: Immediately before, immediately after, and 60 minutes after the intervention. ]
  • Changes in Spinal Reflex Threshold [ Time Frame: Immediately before the intervention and immediately after the intervention. ]
  • Threshold For Detecting Passive Joint Movement [ Time Frame: Immediately before the intervention and immediately after the intervention. ]
  • Accuracy of Direction Estimation of Passive Joint Movement [ Time Frame: Immediately before the intervention and immediately after the intervention. ]

Central Contacts and Locations

Central contacts

Rachel Kalvakota, OTD, OTR/L

3122383947rkalvakota@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Rachel Kravitt, OTD, OTR/L

(312)238-3947rkravitt@sralab.org

Principal Investigator:

Milap Sandhu, PT, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • multiple sclerosis
  • plasticity
  • neuroplasticity
  • motoneuron
  • aih
  • hypoxia
  • Acute Intermittent Hypoxia
  • arm
  • upper extremity

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 2026-02-23.