Status:
COMPLETED
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
Lead Sponsor:
University of Miami
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Conditions:
Sleep Apnea, Obstructive
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Inclusion
- Age 18 or older,
- Chronic (≥ 1-year post-injury), non-progressive SCI,
- Asia Impairment Scale (AIS) C or D,
- Resting Saturated oxygen (SaO2) ≥ 95%,
- Cervical injury (C5-C8)
Exclusion
- Currently hospitalized,
- Resting heart rate ≥120 Beats per minute (BPM),
- Resting systolic blood pressure \>180 mmHg,
- Resting diastolic Blood Pressure \>100 mmHg,
- Self-reported history of unstable angina or myocardial infarction within the previous month,
- OSA that is being treated with positive airway pressure therapy,
- Women who know or suspect they may be pregnant or who may become pregnant,
- Known underlying lung disease,
- Pregnant Women,
- Prisoners,
- Unable to consent
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04017767
Start Date
July 16 2021
End Date
July 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136