Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
次要结局
- 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)
研究者
Shirin Shafazand
Professor
University of Miami