Prospective Exploratory Study Evaluating Sleep Quality and Sleep-Wake Patterns in Parents of Children With Type 1 Diabetes Before and Several Weeks After Initiating Using RT-CGM of Their Children.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- sleep quality
研究概览
简要总结
The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.
详细描述
Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of children up to 16 years old with type 1 diabetes
排除标准
- •Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.
结局指标
主要结局
sleep quality
时间窗: 1 year
Actigraphy: Sleep Diary:During the weeks participants will wear the actigraph, they will be asked to rate their previous nights' sleep using a very short questionnaire. Pittsburgh Sleep Quality Index (PSQI):
次要结局
- Glycemic control(one year)
研究者
zohar landau
Head of Pediatric Endocrinology Service
Wolfson Medical Center