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临床试验/NCT00747890
NCT00747890Unknown不适用

The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities

Kuopio University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年9月1日最近更新:
适应症

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

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

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry Blomster

PhD

Kuopio University Hospital

研究点 (2)

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