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Acute Intermittent Hypoxia (AIH) for Stroke
N/A
Waitlist Available
Led By Zev Rymer, MD/PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A first time, unilateral, ischemic, hemispheric stroke, confirmed by magnetic resonance imaging (MRI);
Chedoke assessment > 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights
Study Summary
This trial will study the effects of a novel therapy, acute intermittent hypoxia (AIH), in stroke survivors. AIH involves breathing brief bouts of reduced oxygen levels through a face mask. The research team hopes to learn if AIH can help improve muscle strength and coordination in stroke survivors.
Who is the study for?
This trial is for adults who've had their first stroke on one side of the brain, confirmed by MRI. They must be at least 6 months post-stroke, able to move their affected hand, speak and understand English, have a hemoglobin level above 10g/dl, and attend visits with someone's help. Women of childbearing potential must confirm they're not pregnant before therapy.Check my eligibility
What is being tested?
The study tests Acute Intermittent Hypoxia (AIH), where participants breathe in low oxygen levels briefly through a mask—like being high up on a mountain—to see if it helps the brain recover after stroke by releasing certain proteins that improve strength and coordination.See study design
What are the potential side effects?
While specific side effects are not listed here, AIH may cause discomfort similar to being at high altitude such as shortness of breath or lightheadedness during treatment sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke on one side of my brain, confirmed by an MRI.
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My stroke recovery level is above 3 on the Chedoke scale.
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I can open and close my hand.
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I can make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical/neurological status over the duration of the study
Secondary outcome measures
5 minute neurological test
D-KEFS Color-Word Interference Test
Elbow strength
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HypoxiaExperimental Treatment1 Intervention
During 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.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,873 Total Patients Enrolled
69 Trials studying Stroke
6,333 Patients Enrolled for Stroke
Zev Rymer, MD/PhDPrincipal Investigator - Principal Investigator
Shirley Ryan AbilityLab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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