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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.

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+