Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- CPAP Adherence
研究概览
简要总结
A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.
详细描述
In an initial single-arm study, participants with stroke will be tested for OSA and treated with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month treatment period. Multiple behavioral interventions will be used to improve CPAP use, including intensive CPAP technical support, motivational enhancement therapy, and phone and mobile health automated support. The multicomponent behavioral intervention will be optimized to improve CPAP adherence with the engagement and input of stroke survivors.
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
- •Age 18 years or older
- •Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
- •Person providing consent (patient or legally authorized representative) able to be consented in English or Spanish
排除标准
- •Unable to obtain informed consent from participant or surrogate
- •Incarcerated
- •Known pregnancy
- •Current mechanical ventilation, tracheostomy or supplemental oxygen use > 4L/min
- •Current use of positive airway pressure or use within 14 days prior to stroke
- •History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
- •Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
- •Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA)
- •Anticipated inpatient rehabilitation length of stay < 3 nights
结局指标
主要结局
CPAP Adherence
时间窗: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months
次要结局
未报告次要终点
研究者
Sandeep Khot
Professor, School of Medicine
University of Washington