Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea
- Conditions
- Chronic Kidney DiseaseObstructive Sleep Apnea
- Interventions
- Device: CPAP - continuous airway pressure
- Registration Number
- NCT01951248
- Lead Sponsor
- Erling Bjerregaard Pedersen
- Brief Summary
The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water.
Hypothesis:
1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep.
2. Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
3. The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP.
4 Quality of life is improved during treatment with CPAP.
- Detailed Description
Approximately 30 patients with chronic kidney disease and obstructive sleep apnea in moderate to severe degree is examined with central and peripheral 24-h blood pressure monitoring, 1 night home polygraphy to determine the degree of sleep apnea, blood and urine samples to determine levels of u-AQP2, u-ENAC, plasma renin concentration (PRC), s-angiotensin II (p-angII), p-aldosterone, p-vasopressin (p-avp) and p-endothelin, before the start treatment with CPAP for sleep apnea.
After 3 month of treatment all the above described is repeated to determine effects of CPAP treatment on blood pressure levels during the day, changes i apnea hypopnea index (AHI) and the kidneys treatment of salt and water.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
- Obstructive sleep apnea, AHI> 15 (moderate to severe)
- both men and women
- 18-80 years
- lack of desire to participate
- malignant disease
- Abuse of drugs or alcohol
- pregnant and lactating
- incompensated heart failure
- atrial fibrillation
- liver disease (alanine aminotransferase> 200)
- Severe chronic obstructive lung disease (Forced expiratory volume in 1 second <50% predicted)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CPAP treatment CPAP - continuous airway pressure Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment
- Primary Outcome Measures
Name Time Method decrease in systolic night time blood pressure 3 months The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.
- Secondary Outcome Measures
Name Time Method difference in systolic blood pressure at night by central blood pressure monitoring 3 months The difference in systolic blood pressure at night by central 24-h blood pressure monitoring before and after 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency
systolic and diastolic blood pressure throughout the day 3 months The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in night time between measurements with peripheral 24-h blood pressure and central 24-h blood pressure before and after 3 months of treatment with CPAP.
correlation between blood pressure, OSA and kidney function 3 months The correlation between the treatment effect on blood pressure levels on the one hand and the severity of OSA prior to initiation of treatment and renal function measured by estimates glomerular filtration rate, on the other
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. 3 months U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. Difference in these before and after 3 months of treatment
quality af life 3 months difference in the quality of life before and after 3 months of CPAP treatment
Trial Locations
- Locations (1)
Medicinsk Forskning
🇩🇰Holstebro, Denmark