跳至主要内容
临床试验/NCT04017767
NCT04017767已完成不适用

Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)

University of Miami2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月16日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shirin Shafazand

Professor

University of Miami

研究点 (2)

Loading locations...

相似试验