Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Autoregulation index (ARI)
研究概览
简要总结
IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.
To this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age older than 18 years
- •spontaneous sinus rhythm
- •signed informed consent
排除标准
- •Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system
- •Central nervous system disorders
- •subjects under drug therapy that may affect the cardiovascular system
- •pregnancy
- •previous diagnosis of depression
研究组 & 干预措施
HEALTHY SUBJECTS
An experimental setup will be devised for the simultaneous monitoring and recording of EEG, ECG, AP, and R together with CBF in healthy volunteers. The experimental protocol including physiological data recordings includes three sessions lasting 10 minutes each: a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos. The overall duration of the experiment is therefore 30 minutes. A total of 40 short video clips of the duration of 15 seconds each will be presented to a total of 50 voluteers will be recruited for the IDEALE study.
干预措施: Active standing (Diagnostic Test)
结局指标
主要结局
Autoregulation index (ARI)
时间窗: 36 months
ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. Minimum value 0, maximum value 9. ARI\>4 means working autoregulation. ARI\<4 means impaired autoregulation. It will be computed for all participants.
Baroreflex sensitivity
时间窗: 36 months
Baroreflex sensitivity will be measured in ms/mmHg. Minimum value 0. Higher value means a better baroreflex regulation. It will be computed in all participants
Cortical activity
时间窗: 36 months
Power of EEG in Alpha and Beta band will be measured in square microvolt. Minimum value 0.
次要结局
未报告次要终点
研究者
Vlasta Bari
Associate Professor in Bioengineeering
IRCCS Policlinico S. Donato