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临床试验/NCT03255408
NCT03255408招募中1 期

Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia

University of Calgary1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
12
试验地点
1
主要终点
Changes in cerebral blood flow and ventilatory chemoreflexes

研究概览

简要总结

A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses).

详细描述

The investigators will explore the relationship between changes in Cerebral Blood Flow (CBF) and ventilatory chemoreflexes i.e. Acute Ventilatory Response to Hypoxia (AHVR) and Acute Hypercapnic Ventilatory Response (HCVR) before, during and after sleep under normoxic conditions and sleep accompanied by isocapnic Intermittent Hypoxia (IH) among healthy human study participants.

A pharmacological intervention will be utilized to manipulate the CBF in a randomized order. The study participants will also be randomly assigned the order to sleep either under normoxia or IH exposure. The experiments will be separated from one another with an interval of sufficient drug and IH exposure washout period. The venous blood samples and urinary samples will be collected for the vascular biomarkers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

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 adults
  • 18 - 45 years of age
  • Living in Calgary for the past one year
  • Have no medical condition or should not be taking any blood pressure medications.
  • The participant should not be lactose intolerant

排除标准

  • Cerebrovascular, cardio-respiratory, renal and metabolic diseases
  • Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease
  • Pregnancy, obese and sleep-disordered breathing
  • Drug allergies to non-steroidal anti-inflammatories
  • Currently smoking

研究组 & 干预措施

CBF Lowering and Normoxia Sleep

Active Comparator

Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.

干预措施: Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep (Drug)

Placebo and Normoxia Sleep

Sham Comparator

Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.

干预措施: Placebo and Normoxia Sleep (Drug)

Placebo and IH Sleep

Placebo Comparator

Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

干预措施: Placebo and Intermittent Hypoxia Sleep (Drug)

CBF Lowering and IH Sleep

Experimental

Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

干预措施: Drug Lowering CBF and Intermittent Hypoxia Sleep (Drug)

结局指标

主要结局

Changes in cerebral blood flow and ventilatory chemoreflexes

时间窗: ~18 months (from the starting time of recruiting study participants)

The relationship between changes in cerebral blood flow (CBF) and ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses) before and after sleeping under normoxia and intermittent hypoxia exposure among healthy human study participants.

Cerebral blood flow responses and ventilatory chemoreflexes during sleep

时间窗: ~18 months (from the starting time of recruiting study participants)

The relationship between cerebral blood flow (CBF) changes and ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses) during sleep under normoxia and intermittent hypoxia exposure among healthy human study participants.

次要结局

  • Changes in reactive oxygen species and vascular biomarkers(~24 months (from the starting time of recruiting study participants))

研究者

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

Marc Poulin

PhD, DPhil, Professor

University of Calgary

研究点 (1)

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