The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft palate, one might benefit from operative treatment of OSA. The aim of our study is to find out whether an operative treatment is effective in mild OSA patients with carefully assessed anatomical predispositions. Our ultimate goal is to evaluate the effects of operative treatment in mild OSA itself and in the diseases related to OSA. We measure the cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests, the quality of life, the quality of sleep and the inflammatory system in sleep apnea before and after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Age 18-65
- •AHI 5-30 events/h
- •Largened tonsils Grade ≥1
排除标准
- •Age <18 or > 65
- •AHI <5 or >30
- •Tonsil size < 1
- •Severe nasal polyposis
- •Pregnancy
- •Chronic kidney, liver or thyroid disease
- •Active treatment of OSA of any kind
结局指标
主要结局
Apnea Hypopnea Index
时间窗: One year(before and after surgery)
次要结局
- Quality of life(One Year)
研究者
Henry Blomster
PhD
Kuopio University Hospital
