← Back to Search

Device

AIH Therapy for Spinal Cord Injury

N/A

Waitlist Available

Led By Shirin Shafazand, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cervical injury (C5-C8)

Age 18 or older

Must not have

Self-reported history of unstable angina or myocardial infarction within the previous month

Currently hospitalized

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 1 post aih, baseline to day 3 post aih, baseline to day 10, baseline to day 17

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the AIH mask and symptoms related to low oxygen like shortness of breath or dizziness during the treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a heart attack or severe chest pain in the last month.

Select...

I am currently in the hospital.

Select...

I am being treated for sleep apnea with a CPAP or similar device.

Select...

I am unable to give consent by myself.

Select...

I have a diagnosed lung condition.

Select...

I am or might be pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.

The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.

Secondary study objectives

Change in Motor Function assessed via hand grip strength measured by EMG recordings.

Change in Motor Function assessed via hand grip strength measured by MGS.

Change in biomarker levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Moderate to Severe Obstructive Sleep Apnea (OSA)Experimental Treatment2 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 OSAActive Control2 Interventions

Individuals without OSA defined as having AHI less than 5.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

950 Previous Clinical Trials

428,363 Total Patients Enrolled

The Craig H. Neilsen FoundationOTHER

60 Previous Clinical Trials

3,018 Total Patients Enrolled

Shirin Shafazand, MDPrincipal Investigator - University of Miami

Anne Bates Leach Eye Hospital Bascom Palmer Eye Institute, Holtz Children's Hospital, Jackson Memorial Hospital, Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Medicine

University Of Toronto (Medical School)

Stanford University Hospital (Residency)