跳至主要内容
临床试验/NCT01855178
NCT01855178已完成不适用

Pediatric Seizure Alarm: A Pilot Study to Establish Efficacy Parameters

Le Bonheur Children's Hospital1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Efficacy of nocturnal seizure bed alarm

研究概览

简要总结

Nocturnal seizure and Sudden unexplained death in epilepsy patients (SUDEP) are major concerns for parents and creates anxiety and poor sleep conditions for many families dealing with epilepsy. An accurate and reliable system for alerting parents to ongoing seizure activity could make a substantial impact in quality of life and possibly reduce the mortality of epilepsy. No previous studies in the pediatric population have been performed to evaluate this type of monitoring for seizure activity. This is one of the most common questions parents ask in clinic, "Are there any alarms that can tell me when my child is having a seizure at night?" Currently the answer is no. This study has the capability to give us data that may change this answer to yes.

详细描述

For parents of children with epilepsy, seizures occurring in sleep are a major concern. This frequently leads to many nights of lost sleep for parents and also to unfavorable sleeping arrangements, especially for older children and adolescents. Sudden unexplained death in epilepsy patients (SUDEP) is also a major concern for both parents and neurology practitioners. Patients with epilepsy have increased risk of sudden unexplained death compared to the rest of the population. The risk of sudden death in epilepsy is estimated at 24 times the risk of the general population. Specific risk factors for sudden death have been evaluated and the most frequently reported risk factors include: nocturnal seizures, being in bed, and history of generalized tonic -clonic seizures. Interestingly, one case-control study observed a decreased risk of SUDEP with nighttime monitoring or supervision which raises the possibility that some cases of SUDEP may be preventable if another person is able to give assistance. This finding may indicate that some of these deaths may be preventable if a caregiver could be alerted to seizure activity. Use of "baby monitors", apnea monitors and pulse oximeters to monitor their children at night has been attempted by families; however, these devices are not specific to seizure activity and in the case of apnea monitors and pulse oximeters have frequent false alarms leading to further anxiety and sleep disturbance for families. Therefore, there is a need for a product that can reliably detect seizure activity without such frequent false positives as to interfere with sleep and functional life.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • non-epileptic

结局指标

主要结局

Efficacy of nocturnal seizure bed alarm

时间窗: 5 years

Measure the occurrence rate of false alarms. Determine if setting parameters for detection can be established according to age and body weight of child/adult.

次要结局

  • Measure seizure types best detected using seizure bed alarm system(5 years)

研究者

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

James W. Wheless

Principal Investigator

Le Bonheur Children's Hospital

研究点 (1)

Loading locations...

相似试验

Pediatric Seizure Movement Bed Alarm | 临床试验