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临床试验/NCT02752139
NCT02752139已完成不适用

Cerebral Hemodynamics in Sleep Disorders

Yi Yang1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
phase difference(PD) in degree

研究概览

简要总结

The purpose of this study is to determine the relationship between sleep disorders and cerebral hemodynamics.

详细描述

Sleep disorders continue to be the most unrecognized modifiable risk factor for stroke. The relationship between sleep disorders and vascular risk factors and stroke has been well-documented but not fully understood. The investigators hypothesize hemodynamics impairment to be its potential mechanism. It has been reported that sleep-related breathing disorder, a type of sleep disorders, contributed as a risk factor for stroke through hemodynamic and hematologic changes. The purpose of this study is to determine the relationship between different kind of sleep disorders and cerebral hemodynamics, including OSHAS, RLS, RBD, narcolepsy, etc. The dynamic cerebral auto-regulation (dCA) and Transcranial Doppler (TCD) will be used to evaluate cerebral hemodynamics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with sleep disorders
  • meet the Diagnostic Criteria for Sleep Dyssomnias
  • sufficient bilateral temporal bone windows for insonation of the MCA

排除标准

  • middle cerebral artery (MCA) and/or other intracranial and/or extracranial major vascular 4 stenosis/occlusion, as diagnosed by a transcranial Doppler
  • having a prior symptomatic cerebral vascular disease
  • current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability
  • inability to cooperate sufficiently to complete the dCA examination

结局指标

主要结局

phase difference(PD) in degree

时间窗: 6 months

A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

the rate of recovery of cerebral blood flow velocity

时间窗: 6 months

A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

gain in cm/s/mmHg

时间窗: 6 months

A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

次要结局

  • mean MCA blood flow velocity (mCBFV) changes from supine to upright position(6 months)
  • resistance index (RI) changes from supine to upright position(6 months)
  • pulsatility index (PI) changes from supine to upright position(6 months)

研究者

发起方
Yi Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yi Yang

Associated Dean of First Hospital of Jilin University

The First Hospital of Jilin University

研究点 (1)

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