Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
概览
- 阶段
- 不适用
- 干预措施
- Clinic-based and technology-supported sleep intervention
- 疾病 / 适应症
- Epilepsy
- 发起方
- National Taiwan University Hospital
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Objective sleep parameter by actigraphy
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.
详细描述
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
研究者
入排标准
入选标准
- •Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
- •Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
排除标准
- •Children who are bedridden.
- •Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
- •Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.
研究组 & 干预措施
Experimental intervention group
standard pediatric neurology care plus a hybrid in-person and digital sleep education program
干预措施: Clinic-based and technology-supported sleep intervention
Usual care group
standard pediatric neurology care
结局指标
主要结局
Objective sleep parameter by actigraphy
时间窗: Baseline, 3 , 6 , and 12 months after randomization
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. The monitor is a wristwatch-like device with an accelerometer sensitive to body movement. Detected physical motion will be stored as activity counts at 30-second intervals and converted to sleep parameters. Outcome measures derived from actigraphy will include: 1. sleep quantity variables as measured by durations of nighttime, daytime, and total 24 hour sleep. 2. sleep quality variable as measured by sleep efficiency.