Trial Summary
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.
Eligibility Criteria
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.
I am 18 years old or older.
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 have had a heart attack or severe chest pain in the last month.
I am currently in the hospital.
I am being treated for sleep apnea with a CPAP or similar device.
I am unable to give consent by myself.
I have a diagnosed lung condition.
I am or might be pregnant.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of MiamiMiami, FL
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Who is running the clinical trial?
University of MiamiLead Sponsor
The Craig H. Neilsen FoundationCollaborator