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临床试验/NCT01621061
NCT01621061已完成不适用

Sleep Apnea and High Altitude Pulmonary Hypertension in Kyrgyz Highlanders

University of Zurich1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2012年6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
125
试验地点
1
主要终点
Sleep related breathing disturbances

研究概览

简要总结

High altitude pulmonary hypertension, a form of altitude illness that occurs in long-term residents at altitudes >2500 m, is characterized by dyspnea, hypoxemia, impaired exercise performance and hypertension in the pulmonary circulation. Whether sleep related breathing disturbances, common causes of nocturnal hypoxemia in lowlanders, are also prevalent in highlanders and promote pulmonary hypertension in highlanders is unknown. Therefore, the current study will investigate whether highlanders with high altitude pulmonary hypertension have a greater prevalence of sleep apnea than healthy highlanders and lowlanders.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure >50 mmHg measured by echocardiography at altitude of residence.
  • healthy subjects (high altitude controls)
  • Both genders
  • Age >16 y
  • Kyrgyz ethnicity
  • born, raised and currently living at >2500 m
  • healthy subjects currently living at <1000 m (low altitude controls)
  • Exclusion criteria:
  • Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
  • excessive erythrocytosis
  • other coexistent disorders that may interfere with the cardio-respiratory system and sleep
  • regular use of medication that affects control of breathing
  • heavy smoking

排除标准

  • 未提供

结局指标

主要结局

Sleep related breathing disturbances

时间窗: 4 months

Nocturnal oxygen saturation and apnea/hypopnea index

次要结局

  • Disease specific quality of life(4 months)
  • Subjective sleepiness(4 months)
  • Pulmonary artery pressure(4 months)
  • Dyspnea(4 months)
  • Vigilance(4 months)
  • Exercise performance(4 months)
  • Pulmonary function(4 months)
  • Cerebral oxygen saturation(4 months)
  • Mountain sickness(4 months)
  • Generic quality of life(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Konrad E. Bloch

Professor

University of Zurich

研究点 (1)

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