Untreated Sleep-related Breathing Disorders as an Aggravating Factor for Neuropathic Pain, Spasticity and Cardiovascular Dysfunction After Spinal Cord Injury: A Cross-sectional Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview.
详细描述
This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview (qualitative analysis).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Individuals with subacute/chronic (> 1 month after injury) spinal cord injury.
- •Individuals with a mid-cervical/mid-thoracic (levels C5 to T6) spinal cord injury.
- •Individuals with a complete or incomplete (ASIA Impairment Scale A, B, C, or D) spinal cord injury.
排除标准
- •individuals with other disorders of the central nervous system (e.g., sequelae of traumatic brain injury, stroke);
- •Individuals with psychiatric disorders that can interfere with adherence to study;
- •Individuals with neuromuscular diseases;
- •Individuals with history of substance abuse;
- •Individuals with prior history of hypersomnias or sleep apnea under treatment;
- •Individuals with prior history of chronic pain (e.g. fibromyalgia).
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: One night of sleep (up to 10 hours)
The number of apneas and hypopneas per hour of sleep recorded using the ApneaLink device.
次要结局
- Neuropathic pain(Pre-intervention assessment only.)
- Cardiovascular dysfunction(Pre-intervention assessment only.)
- Spasticity(Pre-intervention assessment only.)
研究者
Julio Furlan, MD
Clinical Investigator and Scientist
University Health Network, Toronto