Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AHI
研究概览
简要总结
Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.
Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.
详细描述
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by occlusion of upper airways during sleep. The occlusions results in shortly hypoxia, which awakes the patient. When the patient awakes, activity in the pharyngeal muscles results in opening of the upper airway again.
OSA is associated with overweight. Studies have shown high prevalence (60-94%) of obstructive sleep apnea (OSA) among patients undergoing gastric bypass (bariatric) surgery.
Fifteen studies have investigated the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and the following weight loss. However, a huge number of dropouts biases these studies. The dropout rate in the studies are around 60 percent. No studies are from northern Europe.
The Investigators want to perform a study investigating the prevalence of OSA among over weighted patients undergoing bariatric surgery in Denmark.
The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that they can perform a study without a huge number of dropouts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 35
- •attending bariatric surgery
排除标准
- •retrognathia
- •micrognathia,
- •acromegaly
- •downs syndrome
结局指标
主要结局
AHI
时间窗: Change from baseline in AHI at one year
Obstructive sleep apnoea is defined by the apnoea/hypopnoea index (AHI). This can be accessed by embletta monitoring during sleep.
次要结局
- Circumference of neck(Change from baseline in Circumference at neck at one year)
- weight(Change from baseline in weight at one year)
- mean saturation during sleep(Change from baseline in mean saturation during sleep at one year)
研究者
Jeppe Gram
Doctor, PhD
University of Southern Denmark