Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary
研究概览
简要总结
Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2-12 months.
- •Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.
排除标准
- •Diagnosed comorbid health problem that may disrupt sleep.
- •History of birth prior to 37 weeks gestational age.
结局指标
主要结局
Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary
时间窗: Baseline to 5 days post-intervention
Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention.
次要结局
- Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score(Baseline to post-intervention (approximately 20 days))
- Change in Caregiver Epworth Sleepiness Scale (ESS)(Baseline to post-intervention (approximately 20 days))
- Change in Patient Health Questionnaire-2 (PHQ-2) Score(Baseline to post-intervention (approximately 20 days))