A Three-phase Pilot Study of the Feasibility of the Measurement and Promotion of Sleep and the Circadian Rhythm in a Pediatric Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of monitoring the sleep and circadian rhythm of critically ill children
研究概览
简要总结
A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.
详细描述
Several of the identified sleep disruptors in a pediatric intensive care environment may not be modifiable, including restricting feeding to daytime hours and providing normal daytime light exposure. This study aims to measure the feasibility of measuring sleep and circadian patterns in a PICU during routine care and during 2 focused sleep promotion interventions: timed daytime light exposure (DLE) and daytime feeding restriction (DFR). The overall objective of this study is to test the hypothesis that, with multi-disciplinary efforts, providing chronotherapeutic care will be feasible and that reliably measuring sleep patterns and the CR of critically ill children with timed salivary melatonin assays and actigraphy is possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child age 3 to 6 years old on the day of PICU admission
- •English-speaking parent at the bedside
- •Child expected to remain in the PICU over 24 to 48 hours
排除标准
- •Child is in end-of-life care
- •The child is receiving neuromuscular blockade for any reason
- •Caregiver or parent not at the bedside
研究组 & 干预措施
Phase 1: standard of care
10 children will be enrolled in the first phase related to determining if using actigraphy and timed saliva melatonin samples can be a feasible way to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old while they receive routine critical care.
Phase 2: Daytime light exposure
10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while receiving timed exposure to a light box of 10,000 lux within 3 feet of their hospital bed for PICU days #2, 3 and 4.
干预措施: Daytime light exposure (Other)
Phase 3: Daytime restricted feeding
10 children will undergo the same sleep monitoring and salivary melatonin sampling as phase 1 while attempting to limit all nutrition (parental or enteral) to being provided during the normal hours that the child is awake at home on PICU days #2, 3, 4.
干预措施: Daytime restricted feeding (Other)
结局指标
主要结局
Feasibility of monitoring the sleep and circadian rhythm of critically ill children
时间窗: PICU Day 1 through 4
The number of days that reliable sleep and CR data are obtained using an actigraph and serial salivary melatonin assays
次要结局
- Feasibility of providing daytime light exposure(PICU Day 2 through 4)
- Feasibility of restricting nutrition to daytime hours(PICU Day 2 through 4)
研究者
Amanda B. Hassinger
Clinical Associate Professor of Pediatric Sleep Medicine
State University of New York at Buffalo