The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- reported sleep duration (hours)
研究概览
简要总结
The presence of protein in urine is a common laboratory finding in children. Although proteinuria is usually benign, it can be a marker of a serious underlying renal disease or systemic disorder. Microalbuminuria can be one of the first subclinical manifestations of endothelial dysfunction and is associated with low grade systemic inflammation. Multiple studies from the adult population suggest that microalbuminuria above the upper quartile is linked with increased risk of coronary heart disease and death even after adjustment for the presence of diabetes mellitus, obesity and hypertension.
Obstructive sleep apnea (OSA) has been recognized as an independent risk factor for cardiovascular morbidity related to sympathetic nervous system overflow, metabolic dysregulation, inflammation and endothelial dysfunction secondary to repetitive hypoxia -reoxygenation events.
Therefore, there is a need for further studies to investigate the association between OSA and microalbuminuria in children. Furthermore, no studies have thus far investigated the association between other sleep disorders such as periodic limb movement (PLMD) and microalbuminuria in children.
Our hypothesis is that children with sleep disorders or short sleep duration have increased risk of proteinuria/microalbuminuria and that treatment and resolution of the sleep problem will be followed by improvement in proteinuria levels.
详细描述
200 children aged 2-18 years that will be referred to the Sleep Disorders Center for overnight polysomnography due to suspected sleep disordered breathing or PLMD will be recruited to the study during their first visit in the sleep clinic. During that study, an informed consent will be completed by the parents. Data on weekdays and weekends sleep duration as well as personal and family history of kidney disease will be collected.
Exclusion criteria:1. Known renal disease; 2. diabetes mellitus; 3. current use of ACE inhibitors or angiotensin receptor blockers; 4. neuromuscular disorders or craniofacial abnormalities; 5. syndromic conditions.
All participants will undergo physical examination. Weight and height will be measured, and body mass index (BMI) z-score will be calculated.
Blood pressure will be measured on the first visit in the sleep clinic by a trained physician as specified in recent guidelines. 19
Overnight polysomnography will be carried out in the Sleep Disorders Laboratory and the following signals will be recorded: electroencephalogram (EEG; C3/M2, C2/M1, O1/M2, O2/M1); right and left oculogram; submental and tibial electromyogram; body position; electrocardiogram; thoracic and abdominal wall motion; oronasal airflow (three-pronged thermistor and nasal pressure transducer); and oxygen saturation of hemoglobin (SpO2). Arousals, sleep stages and respiratory events will be scored, and polysomnography indices will be defined according to the recent American Academy of Sleep Medicine recommendations . 20
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 2-17 years
- •Referred to overnight PSG due to suspected OSA or PLMD
- •referred for evaluation in the nephrology clinic due to proteinuria
排除标准
- •Known renal disease;
- •diabetes mellitus;
- •current use of ACE inhibitors or angiotensin receptor blockers;
- •neuromuscular disorders
- •craniofacial abnormalities
- •syndromic conditions.
研究组 & 干预措施
children referred to PSG due to suspected SDB
干预措施: PSG (Diagnostic Test)
结局指标
主要结局
reported sleep duration (hours)
时间窗: 1 year
morning urine protein/creatinine >0.2 post treatment of OSA
时间窗: 1 year
morning urine protein/creatinine >0.2
时间窗: 1 year
次要结局
未报告次要终点