Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Profile of Mood States (POMS) - Fatigue Subscale
研究概览
简要总结
There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.
详细描述
Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that >50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens.
This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied.
The study will shed light on the impact of OSA on stroke patients' burdens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke survivor in stroke rehabilitation unit
- •age 45-85
- •able to consent
- •no prior treatment with CPAP
排除标准
- •complex apnea
- •known inflammatory disease
- •neurological disease precluding patient's ability to consent and cooperate
结局指标
主要结局
Profile of Mood States (POMS) - Fatigue Subscale
时间窗: 10 days after beginning CPAP treatment
POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue
次要结局
- Hospital Anxiety and Depression (HADS) Scale -Depression Subscale(10 days after beginning CPAP treatment)
研究者
Joel E. Dimsdale, M.D.
Professor
University of California, San Diego