Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.

Not Applicable

• Conditions: Obstructive Sleep Apnea; Hypertension
• Interventions: Device: CPAP

• Registration Number: NCT02078778
• Lead Sponsor: Erling Bjerregaard Pedersen

Brief Summary

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:

1. 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.

2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.

3. The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.

4. Quality of life improves during treatment with CPAP

Detailed Description

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-01
• Study First Posted: 2014-03-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-30
• Last Update Posted: 2015-02-02
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CPAP	Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.

Primary Outcome Measures

Name	Time	Method
difference in systolic peripheral BP at night	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.

Secondary Outcome Measures

Name	Time	Method
Difference i central systolic BP	3 months	The difference in systolic BP at night in central BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.
Difference i BP throughout the day	3 months	The difference in systolic BP and diastolic BP throughout the day, in the daytime and in nighttime between measurements with peripheral and central 24-h blood pressure monitoring before and after 3 months of treatment with CPAP.
Correlation between degree of OSA and kidney function on effect of treatment	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 as measured by estimated glomerular filtration rate (eGFR) on the other.
urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)	3 months	Changes in U-AQP2 and u-ENaC in 24-h urine samples before and after 3 month of treatment.
Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).	3 months	Changes in PRC, p-AngII, p-Aldo. P-AVP and p-endothelin in blood samples before and after 3 month of treatment.
Quality of life	3 months	Changes in the quality of life before and after treatment of OSA with CPAP.

Trial Locations

Locations (1)

Department of Medical Research and Medicine, Holstebro Regional Hospital; 🇩🇰 Holstebro, Denmark