A Randomly Controlled Study to Explore the Effect of Oral Tube Feeding on Sleep Quality in Stroke-related Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
Palliation to stroke-related dysphagia continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode.
This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of stroke-related dysphagia on sleep quality. This is a prospective study with patients with dysphagia after stroke. Patients enrolled are randomly divided equally into 2 groups. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.
Their sleep quality are compared at baseline and after study.
详细描述
This study lasts 15 days for each patient. Palliation to stroke-related dysphagia continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode.
This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of stroke-related dysphagia on sleep quality. This is a prospective study with patients with dysphagia after stroke. Patients enrolled are randomly divided equally into 2 groups. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.
Their sleep quality are compared at baseline and after study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age>18 years.
- •Meeting the diagnostic criteria for ischemic stroke .
- •Dysphagia confirmed by Videofluoroscopic Swallowing Study.
- •Clear consciousness.
- •No history of prior stroke.
- •Stable vital signs.
排除标准
- •Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- •Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
- •Pregnant or nursing females.
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: day1 and day15
The Pittsburgh Sleep Quality Index (PSQI) is a widely used questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that are grouped into seven components. Each component is scored from 0 to 3, with a total PSQI score ranging from 0 to 21. A higher score indicates worse sleep quality, while a lower score indicates better sleep quality. Generally, a total score of 5 or higher is considered indicative of poor sleep quality.
次要结局
未报告次要终点
研究者
Babujinaya Cela
The Research Director
Buraidah Central Hospital