Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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,
- •Unable to consent
Outcomes
Primary Outcomes
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.
Time Frame: Baseline
Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.
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.
Time Frame: Baseline
Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.
Secondary Outcomes
- Change in Motor Function assessed via hand grip strength measured by EMG recordings.(Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17)
- Change in Motor Function assessed via hand grip strength measured by MGS.(Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17)
- Change in biomarker levels(Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17)
Investigators
Shirin Shafazand
Professor
University of Miami