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临床试验/NCT05146089
NCT05146089已完成早期 1 期

Reflex Responses to Intermittent Hypoxia in Humans: Mechanisms and Consequences

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
54
试验地点
2
主要终点
Muscle sympathetic nerve activity (MSNA)

研究概览

简要总结

The overall goal of this project is to better understand the effect of intermittent hypoxia (IH) on sympathetic neuronal discharge patterns in humans, as well as mechanisms that mediate persistent sympathoexcitation with IH.

详细描述

Sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea exhibit persistent activation of the sympathetic nervous system. Sympathoexcitation is also the final common pathway for a host of complications in conditions like obesity, hypertension, sleep apnea, and heart failure and plays a significant role in predicting negative clinical outcomes and deteriorating cardiovascular health. However, the mechanisms of sympathoexcitation with sleep apnea are poorly understood and thus make effective therapeutic approaches difficult to develop.

Intermittent hypoxia (IH) has been implicated in animal models as the primary stimulus for evoking increases in sympathetic activity with recurrent apneas. Thus, the overall goal of this application is to better understand the effect of IH on sympathetic discharge patterns in humans as well as the mechanisms mediating persistent sympathoexcitation with IH. By better understanding the effect of IH on sympathoexcitation, targeted therapeutic approaches might be devised to mitigate the effects of sympathetic over-activity on the cardiovascular system in conditions such as sleep apnea.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • healthy adult men and women;
  • 18-45 years of age;
  • BMI <30 kg/m2;
  • non-pregnant/non-breastfeeding;
  • non-smokers.

排除标准

  • Subjects will be excluded if they are:
  • taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc);
  • Apnea Hypopnea Index >10 events/hr
  • Self-reported history of:
  • hepatic, renal, pulmonary, cardiovascular, or neurological disease;
  • stroke or neurovascular disease;
  • bleeding/clotting disorders;
  • sleep apnea or other sleep disorders;
  • diabetes;
  • history of alcoholism or substance abuse;
  • hypertension.

研究组 & 干预措施

Hypoxia Exposure

Experimental

Men and women will be exposed to acute intermittent hypoxic episodes.

干预措施: Hypoxic exposure (Other)

Hypoxia Exposure

Experimental

Men and women will be exposed to acute intermittent hypoxic episodes.

干预措施: modified Oxford test (Other)

Hypoxia Exposure

Experimental

Men and women will be exposed to acute intermittent hypoxic episodes.

干预措施: Oral Bosentan 62.5 mg (Drug)

Hypoxia Exposure

Experimental

Men and women will be exposed to acute intermittent hypoxic episodes.

干预措施: Hypoxic ventilatory response test (Other)

结局指标

主要结局

Muscle sympathetic nerve activity (MSNA)

时间窗: Change from baseline after hypoxia exposure

MSNA burst incidence (bursts/100 heart beats)

次要结局

  • Arterial blood pressure(Change from baseline after hypoxia exposure)

研究者

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

Jacqueline K Limberg, PhD

Assistant Professor

University of Missouri-Columbia

研究点 (2)

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