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临床试验/NCT02766595
NCT02766595Unknown不适用

Hyperventilation During Routine EEG in Children: the Impact of Body Position - Sitting vs Supine- on the Yield of the Procedure in Provoking Absence Seizures

Meir Medical Center0 个研究点目标入组 50 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG.

研究概览

简要总结

Children referred for routine EEG studies for suspected absence seizures will be asked, upon caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine position and while sitting up. We aim to demonstrate that hyperventilation is more effective in eliciting absence seizures in a sitting position than while lying down.

详细描述

Hyperventilation is a very effective means of eliciting absence seizures in children with absence epilepsy. Worldwide EEG protocols for routine EEG recording include 3 minutes of hyperventilation. The whole EEG recording, including hyperventilation, is performed with the child lying down on a bed/coach. Our clinical experience suggests that the body position may affect the yield of hyperventilation in provoking the absence event. That is, hyperventilation may be more effective when the child is sitting up, Therefore, children referred for a routine EEG for suspected absence seizures will add 3 minutes of hyperventilation on a sitting position to the routine 3 minutes of supine hyperventilation. At least 5 minutes of rest will be allotted between both procedures.

Patients' caregivers will sign an informed consent form. Patients will randomly be divided into 2 groups: one group will first perform supine hyperventilation followed by sitting hyperventilation; the second group will perform hyperventilation in the opposite order, ie, first sitting up and then in supine position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children referred for a routine EEG for suspected absence epilepsy

排除标准

  • •Patients unable to perform hyperventilation
  • •Children previously diagnosed with absence epilepsy
  • •Children receiving antiepileptic drugs

研究组 & 干预措施

hyperventilation

Other

Non-drug: performing hyperventilation while sitting up during routine EEG

干预措施: hyperventilation while sitting up during routine EEG (Other)

结局指标

主要结局

Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG.

时间窗: 6 months

patients to be divided into 3 groups: Response A: occurrence of absence within 0-60 seconds; response B: within 60 - 120 seconds; response C: no occurrence of absence.

次要结局

  • Influence of order of performing hyperventilation, first supine and then sitting up, or vice-versa, on the time (in seconds) to occurrence of ansence seizures(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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