Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sleep Efficiency by Actigraphy
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 with severe motor dysfunction that prevents accurate sleep-wake differentiation via actigraphy.
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 (Behavioral)
Usual care group
standard pediatric neurology care
结局指标
主要结局
Sleep Efficiency by Actigraphy
时间窗: At baseline and at 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. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.
次要结局
- Sleep Onset Latency(At baseline and at 3, 6, and 12 months after randomization.)
- Wake After Sleep Onset (WASO)(At baseline and at 3, 6, and 12 months after randomization.)
- Total Nighttime Sleep(At baseline and at 3, 6, and 12 months after randomization.)
- Daily 24-hour Sleep Duration(At baseline and at 3, 6, and 12 months after randomization.)
- Children's Sleep Habits Questionnaire (CSHQ)(At baseline and at 3, 6, and 12 months after randomization.)
- Child Behavior Checklist (CBCL)(At baseline and at 3, 6, and 12 months after randomization.)
- Pittsburgh Sleep Quality Index(At baseline and at 3, 6, and 12 months after randomization.)
- Center for Epidemiologic Studies Depression Scale(At baseline and at 3, 6, and 12 months after randomization.)