Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing in Spinal Cord Injured People
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).
详细描述
SCI is a potentially catastrophic event for individuals who may sustain motor, sensory, and autonomic deficit, as well as secondary conditions including SRBDs. The SRBDs include central, obstructive and mixed sleep apnea that can occur in up to 50% of the paraplegics and up to 91% of the motor complete tetraplegics. Although the frequency of SRBDs after SCI is much greater than in able-bodied people, this condition is still a largely under-recognized in the SCI population.
With this, the investigators hypothesize that regular use of CPAP for treatment of moderate-to-severe SRBDs in individuals living with SCI significantly improve their fatigue, depressive symptoms, anxiety, cognitive impairment, quality of life, and social and work participation. This research project will include: (i) a single-arm clinical trial to evaluate the efficacy of nightly use of CPAP for 4 consecutive months in the management of moderate-to-severe SRBDs among 24 adults with subacute to chronic, cervical or thoracic, complete or incomplete SCI; and (ii) a qualitative study of the challenges experienced by the 24 people with SCI who undergo an unattended-hospital or home-based sleep study for diagnosis of SRBDs followed by CPAP therapy.
Overall, this clinical study has the potential to ultimately improve fatigue, mood, cognition, quality of life, and social and work participation of people living with SCI, by examining under-explored links with the SRBDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •English-speaking adults 18 years of age or older
- •Have traumatic cervical/thoracic (injury level at C5 to T10), severe or moderate (AIS A, B, or C) SCI who were not diagnosed with a sleep disorder prior to the injury.
- •At least 2 months after injury
- •Clinical warning symptoms and/or signs for SRBDs
排除标准
- •Patients with a non-traumatic spinal cord disease at risk for neurologic progression
- •Concomitant diseases of the central nervous system
- •Preinjury chronic pain
- •Psychiatric disorders that may prevent the participant to be compliant to the study protocol requirements
- •Neuromuscular diseases
- •Current substance misuse
- •History of primary hypersomnia
- •Hypothyroidism
- •Moderate or severe iron deficiency anemia
- •Active infection
- •Kidney failure
- •Chronic fatigue syndrome
- •Vitamin B12 deficiency
结局指标
主要结局
Fatigue Severity Scale
时间窗: Change in Fatigue Severity Scale from baseline to after 4-month period of CPAP therapy
Self-reported (or administered by an interviewer) scale where participants choose one of seven levels of agreement for each question. Range from 9 (best outcome) to 63 (worst outcome). The primary outcome is the difference between post-intervention and pre-intervention Fatigue Severity Scales.
次要结局
- Epworth Sleepiness Score(Change in Epworth Sleepiness Score from baseline to after 4-month period of CPAP therapy)
- Medical Outcomes Study Sleep Scale(Change in Medical Outcomes Study Sleep Scale from baseline to after 4-month period of CPAP therapy)
- Depression, Anxiety & Stress Scales- 21(Change in Depression, Anxiety & Stress Scales- 21 from baseline to after 4-month period of CPAP therapy)
- Montreal Cognitive Assessment (MoCA) test(Change in Montreal Cognitive Assessment (MoCA) score from baseline to after 4-month period of CPAP therapy)