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.
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jul 2019
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJanuary 18, 2024
October 1, 2023
2.6 years
June 19, 2019
January 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical/neurological status over the duration of the study
All adverse events will be reviewed for safety and study continuation by the medical monitor.
6 days
Secondary Outcomes (8)
National Institute of Health Stroke Scale (NIHSS)
6 days
Fugl- Meyer Assessment
6 days
Modified Ashworth Scale
6 days
Grip strength
6 days
Pinch Strength
6 days
- +3 more secondary outcomes
Study Arms (1)
Hypoxia
EXPERIMENTALDuring each session, study participants will receive a single sequence of AIH, consisting of 15 x 60-seconds periods of hypoxia alternating with 90-seconds of normoxia (21% O2), for a total of 30 minutes, whilst in a seated upright position. AIH will be applied by directing gas flow to a reservoir bag connected via plastic tubing to a non re-breathing facemask/respiratory valve system while the participants are in a seated position. Defined gas mixtures will be delivered by manual adjustment of one-way valves attached to a hypoxia generator.
Interventions
An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered to the subject. Inspired fraction of oxygen (FiO2) of the gas mixture will be individually adjusted using the valve settings to reach the targeted SpO2. The gas mixtures administered during the four sessions will be 21% O2 (target SpO2 = 95%), 17% O2 (target SpO2 = 92%), 13% O2 (target SpO2 = 87%) and 9% O2 (target SpO2 = 82%).
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Related Publications (1)
Pearcey GEP, Barry AJ, Sandhu MS, Carroll TJ, Roth EJ, Rymer WZ. Acute Intermittent Hypoxia in People Living With Chronic Stroke: A Case Series. Stroke. 2025 Apr;56(4):1054-1057. doi: 10.1161/STROKEAHA.124.046620. Epub 2025 Feb 25.
PMID: 39996325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zev Rymer, MD/PhD
Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Single Motor Unit Laboratory, Research Arms + Hands Lab
Study Record Dates
First Submitted
June 19, 2019
First Posted
July 15, 2019
Study Start
July 15, 2019
Primary Completion
February 1, 2022
Study Completion
March 1, 2024
Last Updated
January 18, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share