Sleep Disturbance as a Non-Traditional Risk Factor in CKD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects.
研究概览
简要总结
This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to Moderate CKD
- •Healthy controls age and gender matched to CKD subjects
- •Regular bedtimes of at least 6h/night, sedentary lifestyle
排除标准
- •Current or previous dialysis for more than 1 month
- •Uncontrolled hypertension
- •Heart failure
- •Liver disease
- •Hemoglobin < 10.5 g/dl
- •Treatment with EProcrit, Epogen, or Aranesp
- •Bone or organ transplant,
- •Use of immunosuppressive drugs within past 6 months
- •Current oral contraceptive use
- •Current pregnancy
- •Chemotherapy for malignancy within past 2 years
研究组 & 干预措施
Baseline
CKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time
CKD- Sleep extension
Measures as in baseline but with bed time increased by 2 hours
干预措施: CKD- sleep extension (Other)
Controls short sleep
Measures as in baseline but with sleep disruption
干预措施: Controls Short sleep (Other)
结局指标
主要结局
Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects.
时间窗: Immediately after intervention.
次要结局
未报告次要终点