NCT04019522Completed
American Heart Association- Stroke/Hypoxia Study
An Exploration of Acute Intermittent Hypoxia as a Tool to Enhance Neural Recovery in Stroke Survivors; a Pilot Safety Study.
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 19 Jun 2019
- Start date
- 15 Jul 2019
- Primary completion date
- 1 Feb 2022
- Lead sponsor
- Shirley Ryan AbilityLab
- Diseases
- Stroke
- NCT number
- NCT04019522
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 15 Jul 2019 to the primary completion date, 1 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior neurological disorder;
Other illness
- Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI ≥3
- Pre-existing hypoxic pulmonary disease,
- Severe hypertension (\>160/100)
- Ischemic cardiac disease.
Other
- Severe aphasia, preventing subject from understanding the protocol and giving written consent;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shirley Ryan AbilityLab Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.