Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— NOSI  

Official title:

Central and Peripheral 24-h Blood Pressure Measurements in Patients With Chronic Renal Failure and Obstructive Sleep Apnea Before and After Treatment With CPAP

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01951248
• Other study ID #: BGH-3-2013
• Secondary ID: M-2013-285-13
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2013
• Last updated: October 8, 2014
• Start date: December 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2014
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Chronic Kidney Disease
• Kidney Diseases
• Obstructive Sleep Apnea
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP - continuous airway pressure
3 months of treatment with CPAP treatment

Locations

Country	Name	City	State
Denmark	Medicinsk Forskning	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in systolic night time blood pressure	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.	3 months	No
Secondary	difference in systolic blood pressure at night by central blood pressure monitoring	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	3 months	No
Secondary	systolic and diastolic blood pressure throughout the day	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.	3 months	No
Secondary	correlation between blood pressure, OSA and kidney function	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	3 months	No
Secondary	U-AQP2 and u-ENaC? in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.	U-AQP2 and u-ENaC? in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. Difference in these before and after 3 months of treatment	3 months	No
Secondary	quality af life	difference in the quality of life before and after 3 months of CPAP treatment	3 months	No