Acute Intermittent Hypoxia (AIH) for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan AbilityLab, Chicago, IL
Stroke+1 More
Acute Intermittent Hypoxia (AIH) - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new therapy may help improve motor function for individuals who have had a stroke.

See full description

Eligible Conditions

  • Stroke

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Acute Intermittent Hypoxia (AIH) will improve 1 primary outcome and 8 secondary outcomes in patients with Stroke. Measurement will happen over the course of 6 days.

6 days
5 minute neurological test
Clinical/neurological status over the duration of the study
D-KEFS Color-Word Interference Test
Elbow strength
Fugl- Meyer Assessment
Grip strength
Modified Ashworth Scale
National Institute of Health Stroke Scale (NIHSS)
Pinch Strength

Trial Safety

Trial Design

1 Treatment Group

Hypoxia
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Acute Intermittent Hypoxia (AIH) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Hypoxia
Other
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 days for reporting.

Who is running the study

Principal Investigator
Z. R.
Zev Rymer, Director Single Motor Unit Laboratory, Research Arms + Hands Lab
Shirley Ryan AbilityLab

Closest Location

Shirley Ryan AbilityLab - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

How many people get anoxia a year in the United States?

"Around 700 deaths/year in the US are due to suffocation from an anoxic condition. The death rate is highest among those 45–64 years of age, with the average age of death being 63 years." - Anonymous Online Contributor

Unverified Answer

What causes anoxia?

"In a recent study, findings demonstrates that anoxia and hypoxia induce an adaptive change in the central nervous system, which can alter its excitability-control of the body. The changes observed are discussed in relation to the etiology of the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of anoxia?

"As anoxia [causes] neurological, autonomic, and circulatory manifestations, it is important for doctors to [recognize and understand] these symptoms, such as [generalized tonic-clonic seizures] in [the absence of] a [diagnostic algorithm]." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anoxia?

"Anoxia is a common cause of death among hospital patients. In the United States, anoxia and oxygen toxicity are the ninth leading cause of death in emergency medicine." - Anonymous Online Contributor

Unverified Answer

What is anoxia?

"It's a new definition of anoxia, if the partial pressure of oxygen is less than 12 mm Hg for longer than 60 minutes. Because oxygen content may be measured in milligrams of oxygen, this makes anoxia a measurable number. A lower percentage of oxygen can be measured or measured with other techniques. Anoxia can be encountered under other pathological conditions such as hypothermia or acidosis. Also, anoxia is one of the key mechanisms in certain medical diagnoses such as cardiac arrest and asphyxia." - Anonymous Online Contributor

Unverified Answer

Can anoxia be cured?

"With medical supervision and proper treatment, some survivors of acute cerebral hypoxia may become fully functional if given the proper rehabilitation regimen within 24 hours of a hypoxic episode. The best results in this area appear to be achieved if a multidisciplinary team is assembled and the treatment plan formulated by the specialists on call." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for anoxia?

"The patient should be the one who will choose if participating in a clinical trial for anoxia. On the other hand, we should not recommend to a man who is not suffering from anoxia to participate to a clinical trial of anoxia." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of acute intermittent hypoxia (aih)?

"We hypothesize that Aih induced hypoxia and anoxia in the brain are in vivo toxic for central and peripheral nervous system tissues; they may cause severe damage to both the peripheral and the central nervous system. These side effects may be relevant to the negative effect of Aih on cognitive function and memory in anoxia." - Anonymous Online Contributor

Unverified Answer

How serious can anoxia be?

"During anoxia the body will go through two phases of oxidative damage. The initial damage occurs on the cellular membrane, with oxidative modification of membrane components which can lead to cell death. During the two weeks phase the membrane will be damaged further, leading to cell death. This damage is more difficult to manage, as it increases with duration of anoxia and worsens with the number of cells dying. Although there is a high rate of anoxic injuries from anoxia; almost all fatal anoxic injuries occurred during a period of anoxia in which neither the patient nor the resuscitative team had noticed an issue. The severity of an anoxic injury is dependent on the duration and severity of the anoxia." - Anonymous Online Contributor

Unverified Answer

Has acute intermittent hypoxia (aih) proven to be more effective than a placebo?

"Aih showed improvement in all of the secondary outcomes, confirming the hypothesis that Aih is more effective than a placebo in reversing cognitive impairment after 3 hours of severe hypoxia in healthy adults." - Anonymous Online Contributor

Unverified Answer

Does anoxia run in families?

"In a recent study, findings of our study suggest that anoxia may not run in families. The study highlights the importance of familial testing when interpreting the results of studies of anoxia." - Anonymous Online Contributor

Unverified Answer

How does acute intermittent hypoxia (aih) work?

"The response of iox(h) to aih demonstrates the mechanism by which iox(h) induces apoptosis in HL-60(leukaemic) cells. Additionally, our data suggest that aih can induce iox(h) in HL-60(leukaemic) cells via downregulation of antioxidant defenses. Overall, our data indicates that aih may contribute to the development of anoxia-induced cell injury by decreasing antioxidant defenses. The beneficial effects of iox(h) against aih cannot be completely explained by its free radical scavenging activity alone, but likely also involves other mechanisms, such as inhibition of the pro-apoptotic pathway." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Stroke by sharing your contact details with the study coordinator.