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临床试验/NCT00757718
NCT00757718已完成不适用

Sleep Disordered Breathing and Gestational Hypertension

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Effectiveness of the two treatment arms at treating sleep disordered breathing.

研究概览

简要总结

Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton pregnancies who have the diagnosis of gestational hypertension.

排除标准

  • Inability to comply with study parameters
  • Delivery expected within 48 hours

结局指标

主要结局

Effectiveness of the two treatment arms at treating sleep disordered breathing.

时间窗: single night

次要结局

  • Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.(single night)
  • Acceptability of therapy(single night)

研究者

申办方类型
Other

研究点 (2)

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