Central and Peripheral 24-h Blood Pressure Monitoring in Patients With Hypertension and Obstructive Sleep Apnea Before and After Treatment With Continuous Positive Airway Pressure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- difference in systolic peripheral BP at night
研究概览
简要总结
The purpose of this study is to examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA).
Hypothesis:
-
Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure more accurately than peripheral 24-h BP monitoring, because the measurement is painless and does not interfere with the patient / subject's activities during the daytime or nighttime sleep.
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Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
-
The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.
-
Quality of life improves during treatment with CPAP
详细描述
Approximately 20 patients with hypertension and moderate to severe OSA are treated with CPAP 3 months to examine the treatment effect on blood pressure throughout the day, but especially nocturnal, renal treatment of salt and water, and quality of life.
Before and after 3 months of CPAP treatment is made central and peripheral 24-h ambulatory blood pressure monitoring, 24-h urine collection and blood samples.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic kidney disease (CKD stage I and II), eGFR 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
- •Obstructive sleep apnea, apnea hypopnea index (AHI) > 15 (moderate to severe)
- •Both men and women
- •55-70 years
- •Signed consent form
排除标准
- •Lack of desire to participate
- •Malignant disease
- •Abuse of drugs or alcohol
- •Pregnant and breastfeeding
- •Incompensated heart failure
- •Atrial fibrillation
- •Liver disease (Alanine aminotransferase (ALT) > 200)
- •Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second <50% predicted)
- •Blood pressure difference between the right and left arm> 10/10 mmHg
结局指标
主要结局
difference in systolic peripheral BP at night
时间窗: 3 months
The difference in systolic BP at night by peripheral BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.
次要结局
- Difference i central systolic BP(3 months)
- Difference i BP throughout the day(3 months)
- Correlation between degree of OSA and kidney function on effect of treatment(3 months)
- urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)(3 months)
- Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).(3 months)
- Quality of life(3 months)
研究者
Erling Bjerregaard Pedersen
professor
Regional Hospital Holstebro