AIH Therapy for Spinal Cord Injury

Overseen By Shirin Shafazand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Lung disease, Heart issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how sleep apnea (a sleep disorder with breathing interruptions) and low oxygen levels affect muscle strength and lung function in individuals with long-term spinal cord injuries. Participants will use an AIH mask, which creates short bursts of low oxygen, to assess its potential impact. The trial includes two groups: one with moderate to severe sleep apnea and another without sleep apnea. Eligible participants must have had a spinal cord injury for at least a year, a neck injury between C5 and C8, and must breathe comfortably at rest, as indicated by a specific oxygen level in their blood. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of spinal cord injuries.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AIH mask and Induced Acute Intermittent Hypoxia (AIH) are safe for individuals with spinal cord injury?

Research has shown that the AIH mask treatment, which uses Induced Acute Intermittent Hypoxia (AIH), is generally safe. Studies have found that AIH helps the body adjust without affecting brain function or its blood supply, meaning it doesn't interfere with cognitive processes or cerebral circulation.

The treatment has been tested in various situations, such as hand exercises and walking training. Results showed improvements in hand use and walking, with no major safety issues reported. These findings suggest that AIH is well-tolerated and can be safely used to aid rehabilitation, such as enhancing muscle strength and lung function, particularly for individuals with spinal cord injuries.

Overall, the evidence supports AIH as a safe therapy option, making it a promising treatment for further exploration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AIH therapy for spinal cord injury because it offers a novel approach by using an AIH mask to induce acute intermittent hypoxia. Unlike current treatments that primarily focus on rehabilitation and medication to manage symptoms, AIH therapy aims to enhance neural plasticity and improve motor function by exposing patients to controlled, brief periods of low oxygen. This unique mechanism could potentially kick-start the body's ability to repair and adapt, leading to improved outcomes for those with spinal cord injuries.

What evidence suggests that AIH therapy could be effective for spinal cord injury?

Research has shown that a treatment called acute intermittent hypoxia (AIH) might help people with spinal cord injuries. In this trial, participants will be divided into two groups: those with moderate to severe obstructive sleep apnea (OSA) and those without OSA. Studies have found that just one session of AIH can increase grip and pinch strength, with the best results seen about three hours after treatment. Some evidence also suggests that AIH might improve breathing in people with long-term spinal cord injuries. It may work by changing how nerve cells activate, leading to stronger muscles. These early findings are promising, indicating that AIH could be a useful tool in rehabilitation. ^{2 5 6 7 8}

Who Is on the Research Team?

Shirin Shafazand, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic, non-progressive spinal cord injury (SCI) at least one year post-injury. Participants must have an Asia Impairment Scale of C or D, a cervical injury between C5-C8, and normal oxygen levels. It's not for hospitalized individuals, those with recent heart issues, pregnant women, prisoners, people unable to consent or currently on airway pressure therapy for sleep apnea.

Inclusion Criteria

I have an injury between the C5 and C8 vertebrae in my neck.

My spinal cord injury is over a year old and not getting worse.

I have partial control over my limbs after a spinal injury.

Exclusion Criteria

I am currently in the hospital.

Pregnant Women

Your heart beats more than 120 times per minute when you are resting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of motor function and biomarker levels are taken

1 day

1 visit (in-person)

Intervention

Participants undergo intermittent hypoxia sessions to assess effects on motor function and biomarkers

17 days

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in motor function and biomarker levels post-intervention

17 days

Follow-up assessments on Day 1, Day 3, Day 10, and Day 17

What Are the Treatments Tested in This Trial?

Interventions

• AIH mask
• Induced Acute Intermittent Hypoxia (AIH)

Trial Overview The study investigates the effects of induced low oxygen conditions using an AIH mask on muscle strength and lung function in individuals with chronic SCI. The intervention mimics sleep apnea to understand its impact on motor abilities.

How Is the Trial Designed?

Group I: Moderate to Severe Obstructive Sleep Apnea (OSA) Experimental Treatment 2 Interventions

Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15.

Group II: Without OSA Active Control 2 Interventions

Individuals without OSA defined as having AHI less than 5.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530358/

Efficacy and time course of acute intermittent hypoxia effects in ... We found that a single AIH session enhanced bilateral grip and pinch strength, and that this effect peaked ~3 hours post-intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07002437

Hypoxia Pathways for Early Recovery After Spinal Cord Injury This line of research will inform AIH protocol optimization to enhance the clinical effects of AIH treatments designed to improve rehabilitation ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014488623001371

Acute intermittent hypoxia enhances strength, and ... These data suggest that altered motor unit activation profiles may underlie improved volitional strength after a single dose of AIH and warrant further ...

4. brooksrehab.org brooksrehab.org/resources/researchers-receive-grant-to-study-improved-breathing-for-sci/

Researchers Receive $3.6 Million Grant for Study to ... A new treatment known as therapeutic acute intermittent hypoxia (AIH) has shown promise for improving breathing ability in people living with chronic spinal ...

5. nature.com nature.com/articles/s41598-025-90890-8

Intermittent hypoxia-induced enhancements in ... Our results suggest that AIH-induced gains in excitability predict both the magnitude of motor learning and the associated metabolic efficiency.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5664298/

Effects of acute intermittent hypoxia on hand use after ... Daily acute intermittent hypoxia (AIH) combined with hand opening practice improves hand dexterity, function, and maximum hand opening.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569904824001514

Safety and effectiveness of acute intermittent hypoxia ... AIH is generally safe and effective for inducing neural plastic responses. · AIH does not impact cognition or cerebral perfusion rates. · AIH acutely results in a ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.047261

Acute Intermittent Hypoxia With High-Intensity Gait Training ... The goal of this study was to evaluate the safety and efficacy of AIH+HIT versus HIT alone in individuals with chronic stroke.