NL-OMON50690已完成不适用
Promoting implementation of seizure detection devices in epilepsy care: the PROMISE study - the PROMISE study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Age 4-16 years
- •Diagnosis of refractory epilepsy with >=1 major nocturnal seizure per week.
- •Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
- •Written informed consent by legal representatives (mostly parents) and also
- •by the subject when aged >=12 years and capable of signing informed consent.
排除标准
- •Intensive non-epileptic movement patterns such as severe choreatiform
- •movements, intensive sleep walking, or frequent night terrors (> 1/week).
- •Minor motor seizures only, i.e. non-generalized or short (< 10 sec.) tonic
- •seizures or isolated myoclonias that are self-limited and do not require
- •intervention.
- •Presence of a pacemaker or cardiac arrhythmias that may generate false alarms
- •(e.g. supraventricular tachycardia).
- •Inability to comply to the trial procedure.
- •Skin characteristics (e.g. tattoo) that may affect photoplethysmography and
- •thereby influence performance of the Nightwatch .
- •Dependence on another SDD (e.g. Emfit or saturation monitor). Simultaneous
- •use of a baby phone (or other types of microphones) is permitted.
- •Subjects who are not sleeping alone in the bed (i.e. co-sleeping in the
- •parents*/guardians* bed influences the remote SDD). We do not allow subjects
- •and parents/guardians to change their sleeping habits for the duration of the
- •study only.
研究者
相似试验
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06762340[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04945941[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06733259[Redacted]
已完成
不适用
Clinical Investigation (Beta) of a New Developed Prosthetic KneeNCT06748729Össur Iceland ehf11
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06422065[Redacted]