Acute Intermittent Hypoxia for Stroke

AJ
WZ
Overseen ByWilliam Z Rymer, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new breathing technique called acute intermittent hypoxia to improve motor function in stroke survivors. The treatment involves short periods of breathing low-oxygen air, similar to high-altitude conditions, to potentially boost strength and movement. It targets individuals who had their first stroke more than six months ago, can open and close the affected hand, and are not part of any other similar study. Participants must travel with someone after the research visits. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for stroke patients?

Research has shown that acute intermittent hypoxia (AIH) is generally safe for people who have had a stroke. Studies have found that AIH can improve arm and leg strength and overall movement in individuals with long-term stroke effects. The treatment involves brief periods of breathing air with reduced oxygen, similar to high-altitude conditions, followed by normal air.

Most people tolerate AIH well. Some minor side effects, such as muscle pain, dizziness, or shortness of breath, have been reported, but these are uncommon. Overall, AIH appears to be a safe and potentially beneficial treatment for enhancing physical abilities after a stroke.12345

Why are researchers excited about this trial?

Unlike the standard care for stroke, which often involves medications like anticoagulants and thrombolytics, Acute Intermittent Hypoxia (AIH) offers a novel approach by temporarily exposing patients to lower oxygen levels. This technique mimics high-altitude conditions and aims to stimulate the body's natural protective and recovery mechanisms. Researchers are excited about AIH because it could enhance brain plasticity and repair, potentially improving recovery outcomes beyond what current treatments offer.

What evidence suggests that acute intermittent hypoxia is effective for stroke recovery?

Research has shown that acute intermittent hypoxia (AIH), the treatment participants in this trial will receive, can improve limb strength in stroke survivors. Studies have found that AIH can significantly boost grip strength, with increases of about 13% to 17% after treatment. AIH temporarily strengthens brain connections, potentially enhancing movement. Additionally, AIH supports brain recovery by improving blood flow and reducing damage after a stroke. Previous studies report that this treatment is well-tolerated, with no major side effects.12678

Who Is on the Research Team?

WZ

William Z Rymer, MD, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults who had a single stroke on one side of the brain over 6 months ago, can open and close their affected hand, have enough hemoglobin in their blood, and can understand English. People with other neurological issues, severe heart or lung disease, or recent Covid-related pneumonia cannot join.

Inclusion Criteria

My hand function is at least at stage 3 on the Chedoke assessment.
I had a stroke more than 6 months ago.
I can open and close my affected hand.
See 7 more

Exclusion Criteria

History of prior neurological disorders
I have had a stroke in my brain stem or cerebellum, or my MRI Fazekas score is 3 or higher.
Severe Aphasia
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive approximately 15 bouts of acute intermittent hypoxia, involving breathing lowered levels of oxygen for 60 seconds at a time, followed by 60 seconds of room air.

1 session
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including EKG, joint force measurement, stretch reflex measurement, surface EMG measurement, and symptom checklist.

30 minutes following intervention
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acute Intermittent Hypoxia

Trial Overview

The study tests if brief periods of low-oxygen air (acute intermittent hypoxia) can improve arm and hand function after stroke. Participants will breathe this special air under supervision to see how it affects muscle control.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: HypoxiaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials
212
Recruited
17,900+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Acute Intermittent Hypoxia in People Living With Chronic ...

Our findings suggest that AIH is potentially safely tolerated and effective for improving limb function in people living with chronic stroke.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39996325/

Acute Intermittent Hypoxia in People Living With Chronic ...

Results: AIH was well-tolerated and there were no adverse events observed. After AIH, grip strength (12.91% and 16.53% improvement at 30 and 60 ...

Effects of improving intermittent hypoxia on poststroke ...

Moreover, the IH-RA group demonstrated progressively improved autonomic activity, stable sleep pattern, increased delta brainwave power, and reduced ...

Acute intermittent hypoxia in people living with chronic stroke

Conclusions AIH appears to be potentially safe and effective for improving strength in the more-affected limb in people with stroke. Future work ...

Intermittent hypoxia conditioning as a potential prevention and ...

Applying IH conditioning at different stages of IS may ultimately reduce infarct volume, improve cerebral perfusion, and promote neurological recovery. IH, ...

Safety and effectiveness of acute intermittent hypoxia ...

Acute intermittent hypoxia is generally safe and effective at producing neural plastic responses, but further examination of co-occurring cardiovascular ...

Safety and potential benefits of acute intermittent hypoxia ...

Conclusions AIH dosage as low as 9% O2 appears safe to use in chronic TBI, but its potential benefits remain to be investigated. Competing ...

Acute Intermittent Hypoxia With High-Intensity Gait Training ...

Minor adverse events included musculoskeletal pain, falls without injury, dizziness/loss of consciousness, excessive shortness of breath, or ...