Improving Human Cerebrovascular Function Using Acute Intermittent Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Resting Cerebral Blood Flow
研究概览
简要总结
This study uses magnetic resonance imaging to determine whether 3 weeks of repeated exposure to Acute Intermittent Hypoxia can improve brain blood flow or blood flow regulation in healthy adults.
详细描述
This study aims to identify an intervention to improve the function of blood vessels in the human brain, in order to mitigate damage to overall brain function and improve health outcomes across the lifespan. Hypoxia is a potent driver of angiogenesis and vascular plasticity, and acute intermittent hypoxia (AIH) protocols, in which an individual alternates between breathing mildly hypoxic air and normal air, are being rigorously examined for their potential in improving human physiology. This study tests whether AIH evokes beneficial vascular plasticity in the human brain, using a randomized crossover design to determine the impact of different daily AIH or sham interventions on MRI measures of cerebrovascular physiology.
Healthy, able-bodied participants between 21 and 50 years old will be invited to participate in this study. The daily AIH intervention consists of repeated visits to the PI laboratory over a three-week period to have an AIH or sham protocol administered via a hypoxia generator and face mask (Hyp-123, Hypoxico). Blood pressure readings will be taken before and after all intervention visits, and SpO2 levels continuously recorded for safety monitoring.
The effectiveness of the different interventions at improving cerebrovascular function will be assessed using MRI. In the week prior to each intervention period the participant will undergo MRI scanning. In addition to structural and diffusion weighted scans, multiple perfusion metrics will be extracted. Whole-brain cerebral blood flow will be measured using phase-contrast MRI, and quantitative CBF maps of regional perfusion will be measured using arterial spin labeling MRI. These perfusion metrics will be acquired three times: during normoxic (baseline), hypoxic, and hypercapnic conditions. Changes in perfusion values during gas challenges will measure whole-brain and regional cerebrovascular reactivity. The MRI protocol will be repeated one day after the last intervention visit.
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
- Single (Participant)
盲法说明
Participants will not know whether they are receiving active or sham hypoxia during individual AIH sessions.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between ages of 21 and 50 years
- •No known neurological, respiratory or vascular conditions
- •Safe to be scanned using MRI
- •Able to communicate in English
排除标准
- •MRI contraindications as indicated on MRI safety screening form
- •Subjects with pacemakers, cochlear (in the ear) implants, or aneurysm clips or subjects who have worked with metal
- •Pregnant women
- •Individuals with known neurological or vascular conditions
- •Individuals with sleep apnea, emphysema, or other respiratory conditions
- •Individuals with severe claustrophobia
- •Subjects unwilling or unable to give written informed consent in English
- •Prisoners
- •Frequent smoker
- •Allergy to Tegaderm
- •Blood pressure greater than 140/90 or less than 90/
- •Individuals who report headaches, feeling dizzy or light-headed, or have heart palpitations on the day of the study.
- •Individuals prescribed Aripiprazole and/or Lamotrigine*
- •Note, mild (well-controlled) asthma is not immediate grounds for exclusion.
- •*Other prescription medications may be grounds for exclusion; prescription medication information will be acquired during initial screening and at subsequent follow-up visits
研究组 & 干预措施
Intermittent Hypoxia
Participant will visit our center 2-4 times per week for three weeks to receive Acute Intermittent Hypoxia.
干预措施: Acute Intermittent Hypoxia (Other)
Sham Intermittent Hypoxia
Participants will visit our center 2-4 times per week for three weeks to receive Sham Intermittent Hypoxia.
干预措施: Sham Acute Intermittent Hypoxia (Other)
结局指标
主要结局
Resting Cerebral Blood Flow
时间窗: 4 weeks
Phase-contrast MRI and Arterial Spin Labeling MRI will be used to quantify whole-brain and cortical gray matter perfusion (ml/100g/min) before and after the 3-week intervention.
次要结局
- Cerebrovascular Reactivity(4 weeks)
研究者
Molly Bright
Assistant Professor
Northwestern University