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临床试验/NCT04471740
NCT04471740招募中不适用

Normal-pressure Hydrocephalus. Relationship Between Sleep Apnea and Intracranial and Intraabdominal Pressures. Outcome Prognostic Factors in CSF Shunting. Features Guiding to Implant a Ventricle-peritoneal Versus a Ventriculo-atrial Shunt

University of Valencia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Change of hydrocephalus symptoms with NPH scale after CSF shunt diversion

研究概览

简要总结

Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells. When patients are operated the distal part of the shunt is inserted inside the abdominal cavity, which pressure also increases during the sleep apnea episodes. this is particularly important considering that the recumbent position used to sleep further increases the intraabdominal pressure and that impairs the CSF drainage through the shunt system. The purpose of this study is to analyze the intracranial and intraabdominal pressures during the sleep, particularly during the sleep apnea episodes to see which shunt should be used, to which cavity should be drained (peritoneum or heart) and if correcting the sleep apnea has some positive result on the hydrocephalus symptoms.

详细描述

Chronic hydrocephalus in adults, also known as normal pressure hydrocephalus or normal pressure hydrocephalus, occurs with the classic Hakim-Adams triad, gait ataxia, or "magnetic gait", urinary incontinence and dementia.

Most of the cases have an idiopathic origin and are the only potentially reversible cause of dementia with surgical treatment (by shunting the cerebrospinal fluid or CSF from the lateral ventricles or the thecal sac to the peritoneal cavity or the right atrium), so it is especially important to diagnose it and treat it properly.

Unfortunately, and despite all the diagnostic arsenal, the results of treatment using cerebrospinal fluid shunts (lumbo-peritoneal or ventricle-peritoneal), even in the best series, show 20-25% of poor results. These poor results have been attributed to many factors, including associated cerebral vascular pathology problems, co-existing dementia symptoms not always well diagnosed, Parkinson's disease, and, lastly, alterations in ventilatory rhythm. during the night, specifically obstructive sleep apnea or OSA.

In reality, the name of normotensive hydrocephalus or hydrocephalus at normal pressure is inaccurate because the intracranial pressure does rise and very markedly during sleep, particularly during the REM phase of sleep. What is no longer so well known is because of such significant increases in intracranial pressure occur. One possible explanation would be that obstructive sleep apnea causes increased intracranial pressure. But it remains to be clarified whether all patients with adult chronic hydrocephalus have sleep apnea, the mechanism of action, and to what extent the treatment of hydrocephalus acts on sleep apnea and vice versa.

Another aspect to consider is that the cerebrospinal fluid shunts work by the pressure gradient between the intracranial cavity and the cavity into which the cephalo-spinal fluid is drained66, usually the peritoneal fluid. During sleep apnea, there should be an increase in intra-abdominal pressure, which would result in the ventricle-peritoneal and lumbo-peritoneal shunts working suboptimally precisely at the time of day when they are most needed, that is when intracranial pressure increases. But this correlation has never been investigated or at least there are no publications about it.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients will not be informed of the final treatment decided

入排标准

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

入选标准

  • Clinical condition compatible with normal-pressure hydrocephalus

排除标准

  • Cerebral vascular disease
  • Dementia not due to normal-pressure hydrocephalus
  • Parkinson's disease

研究组 & 干预措施

Normal-pressure hydrocephalus only

Experimental

Patients suffering from normal-pressure hydrocephalus with NO sleep apnea

干预措施: CSF shunt diversion (Procedure)

Normal-pressure hydrocephalus with sleep apnea

Active Comparator

Patients suffering from normal-pressure hydrocephalus with sleep apnea

干预措施: CSF shunt diversion (Procedure)

结局指标

主要结局

Change of hydrocephalus symptoms with NPH scale after CSF shunt diversion

时间窗: 1-2 months

Patients will be evaluated with the NPH before and after CSF shunting to see the degree of improvement they get from this surgical treatment

Change of hydrocephalus symptoms with Mini-Mental State Examination

时间窗: 1-2 months

Patients will be evaluated with the Mini\_mental State Examination before and after CSF shunting to see the degree of improvement they get from this surgical treatment

次要结局

未报告次要终点

研究者

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

Vicente Vanaclocha

Associate Professor of Medicine

University of Valencia

研究点 (2)

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