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Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression

2022年3月27日 更新者：Helle Klingenberg Iversen, MD, DmSc
The purpose of this study is to investigate sleep disordered breathing, autonomic dysfunction, and post stroke depression in acute and chronic stroke patients. Furthermore, to explore the interaction between these comorbidities, and their relation to stroke aetiology.

研究概览

地位

完全的

条件

详细说明

Up to fifty percent of stroke patients suffer less noticeable comorbidities after the acute phase of a stroke and often the rest of their life. It concerns sleep disordered breathing (SDB), post stroke depression (PSD), and dysfunction of the autonomic nervous system. These comorbidities are seldom recognized, but are associated with a poorer outcome after stroke, reduced quality of life as well as an increased risk of new vascular events.

Little is known about the course of the comorbidities, the relationship between the mentioned diseases or which patients are more commonly affected.

The investigators will investigate the following hypotheses, and assess the results compared to the stroke aetiology:

  1. Stroke patients with SDB have an impaired autonomic function
  2. Stroke patients with SDB have an increased risk of PSD
  3. Stroke patients with autonomic dysfunction have an increased risk of PSD

The investigators will examine stroke patients for signs of sleep disordered breathing, autonomic dysfunction and depression, both in the acute phase (days), in the chronic phase (months) and the very chronic state (years). Thereby the investigators can map the comorbidities course over time. At the same time the patients will be tested for peripheral small and large artery disease as well as MRI will be used to investigate sign of cerebral small vessel disease.

Based on power calculations 335 individuals will be enrolled in order to satisfy the project requirements.

研究类型

观察性的

注册 (实际的)

114

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Glostrup、丹麦、2600
        • Department of clinical stroke research, department of neurology, Glostrup Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.

描述

Inclusion Criteria:

• Clinical stroke either ischaemic or haemorrhagic

Exclusion Criteria:

  • Transitory ischemic attac
  • Congenital or acquired brain disease, other than stroke
  • Dementia
  • Mental retardation
  • Fatal stroke or severe comorbidities with short expected life
  • Pregnancy or breastfeeding
  • Altered consciousness e.g. delirium or status epilepticus
  • Other cause of the patient, according to the investigator believes, can not complete the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：预期

队列和干预

团体/队列
Acute stroke
No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Sleep disordered breathing at any time after stroke.
大体时间：six month after stroke

The test for sleep disordered breathing will be performed within 7 days from stroke onset and after 6 month and five years.

Mild sleep apnea if AHI between 5 and 15, moderate sleep apnea if AHI between 15 and 30 and severe sleep apnea if AHI above 30. Subdivided into obstructive, central or mixed.
six month after stroke
Autonomic dysfunction at any time after stroke.
大体时间：six month after the stroke

The test for autonomic dysfunction will be performed within 7 days from stroke onset and after 6 month and five years.

Abnormal result of the valsalva manoeuvre, deep breathing, active standing or tilt table test. Improvement or worsening of the parameters like HRV, BRS and CO during the study period.
six month after the stroke
Depression at any time after stroke
大体时间：six month after the stroke

The test for depression will be performed within 7 days from stroke onset and after 6 month and five years.

Mild, moderate or severe depression according to HAM-D6, MDI or HADS
six month after the stroke

次要结果测量

结果测量
措施说明
大体时间
Peripheral artery disease at any time after stroke
大体时间：six month after the stroke

The tests will be performed within 7 days from stroke onset and after 6 month and five years.

Stenosis of the carotid artery, abnormal ankle-brachial index or endothelial dysfunction.
six month after the stroke

其他结果措施

结果测量
措施说明
大体时间
New vascular episodes at any time after stroke
大体时间：Assessed at follow-up after six month
Assessed at follow-up after six month and five years. Stroke, TIA, acute coronary syndrome or operation for peripheral vascular disease.
Assessed at follow-up after six month
Death by cause at any time after stroke
大体时间：Assessed at follow-up after six month
Assessed at follow-up after six month and five years
Assessed at follow-up after six month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Helle Klingenberg Iversen, MD, DmSc

调查人员

  • 首席研究员：Helle Iversen, MD, DMSc、Stroke research, Glostrup hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年3月1日

初级完成 (实际的)

2017年2月1日

研究完成 (实际的)

2022年3月1日

研究注册日期

首次提交

2014年4月3日

首先提交符合 QC 标准的

2014年4月9日

首次发布 (估计)

2014年4月11日

研究记录更新

最后更新发布 (实际的)

2022年3月29日

上次提交的符合 QC 标准的更新

2022年3月27日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • VEK: H-2-3013-091
  • H-2-3013-091 (其他标识符：Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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