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临床试验/NCT02730143
NCT02730143已完成不适用

Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders

University of Zurich2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Mean nocturnal oxygen saturation measured by pulse oximetry

研究概览

简要总结

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.

详细描述

Respiratory polygraphies will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and respiratory polygraphies will be performed on night 1 and 6. They will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.

A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • born, raised and currently living <800m
  • No overnight stay at altitudes >1500 m 4 weeks before the study

排除标准

  • Previous altitude intolerance to altitude <3000 m
  • Pregnancy
  • Health impairment, which requires regular treatment

研究组 & 干预措施

Altitude exposure

Experimental

Acute high altitude exposure followed by 8 day acclimatization and re-exposure after 6 days at low altitude

干预措施: Altitude exposure (Other)

结局指标

主要结局

Mean nocturnal oxygen saturation measured by pulse oximetry

时间窗: first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1

Change in mean nocturnal oxygen saturation over the course of high altitude exposure during 2 sojourns at 5050 m compared to low altitude

次要结局

  • Acute mountain sickness measured by the Environmental Symptom questionnaire cerebral score (AMSc)(first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2,7; low altitude sojourn at 520 m, day 2)
  • Oxygen desaturation index measured by respiratory polygraphy(first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1)
  • Apnea-/hypopnea index measured by respiratory polygraphy(first sojourn at 5050 m, night 1, 6; second sojourn at 5050 m, night 1, 6; low altitude sojourn at 520 m, night 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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