American Heart Association- Stroke/Hypoxia Study

Completed · Not applicable

Conditions studied: Stroke

In brief

Of the 795,000 people who experience a stroke every year in the US, only a small percentage will achieve full recovery. While current therapies promote strength and endurance, none directly address the unique potential of the brain to reorganize following injury. The goal of this project is to explore the effects of a novel therapy, acute intermittent hypoxia (AIH). During this therapy, individuals receive brief bouts of reduced oxygen levels by inhalation through a face mask. (This is akin to being on top of a tall mountain). In brief exposures, AIH is known to trigger the release of specific proteins that help the brain adapt to oxygen reductions. Published results in people with incomplete spinal cord injury have shown that AIH enhances muscle strength and coordination rather quickly. The research team aims to study the effects of AIH in stroke survivors.

Key facts

Study ID

NCT04019522

Run by

Shirley Ryan AbilityLab

People needed

16

Starts

2019-07-15

Expected to finish

2025-07-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years;
• A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI);
• Chedoke assessment > 3
• Ability to open and close affected hand
• Able to understand and communicate in English
• Be able to consent independently
• ≥ 6 months post stroke
• Must have a hemoglobin level above 10g/dl (to be confirmed using handheld noninvasive lab equipment)
• Must have ability to attend research visits with a companion for assistance
• WOCBP must be comfortable confirming negative pregnancy prior to hypoxia experimental therapy.

You may not qualify if…

• Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3
• Severe aphasia, preventing subject from understanding the protocol and giving written consent;
• History of prior neurological disorder;
• Pre-existing hypoxic pulmonary disease,
• Severe hypertension (>160/100)
• Ischemic cardiac disease.

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.