Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
研究概览
简要总结
This randomized clinical trial will compare three groups of individuals with cervical/thoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •English-speaking adults (18 years of age or older)
- •Acute (≤ 30 days after injury), cervical/thoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI
- •Not being treated for sleep apnea prior to the spinal cord impairment onset.
排除标准
- •Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)
- •Concomitant diseases of the central nervous system
- •Preinjury chronic pain
- •Other pre-existing diseases of the central nervous system
- •Significant psychiatric disorders with recent episode of exacerbation
- •Neuromuscular diseases
- •Current substance misuse
- •Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)
- •Vitamin B12 deficiency
结局指标
主要结局
Change in International from baseline to 6 months after recruitment Standards for Neurological Classification of SCI (ISNCSCI) sensory subscore
时间窗: From baseline to 6 months after recruitment
Sensory assessment of dermatomes in the upper and lower extremities (224: normal; 0: no sensory function)
Change in Spinal Cord Independence Measure (SCIM) - version III - score from baseline to 6 months after recruitment
时间窗: From baseline to 6 months after recruitment
The SCIM scores varies from 0 to 100 and includes the following subscores: self-care (0-20); respiration and sphincter management (0-40); mobility (0-40).
Change in International Standards for Neurological Classification of SCI (ISNCSCI) motor subscore from baseline to 6 months after recruitment
时间窗: From baseline to 6 months after recruitment
Motor assessment of muscles in the upper and lower extremities (100: normal; 0: complete paresis)
次要结局
- Change in Fatigue Severity Scale (FSS) from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Medical Outcomes Study Sleep Scale (MOS-SS) from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Depression, Anxiety & Stress Scales- 21 (DASS-21) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Patient Health Questionnaire (PHQ-9) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)
- Change in Montreal Cognitive Assessment (MoCA test) score from baseline to 6 months after recruitment(From baseline to 6 months after recruitment)