Clinical trial NCT02078778: Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: Continuous airway pressure
Hypertension
Obstructive sleep apnea
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: difference in systolic peripheral BP at night
timeFrame: 3 months
Secondary outcomes:
measure: Difference i central systolic BP
timeFrame: 3 months
measure: Difference i BP throughout the day
timeFrame: 3 months
measure: Correlation between degree of OSA and kidney function on effect of treatment
timeFrame: 3 months
measure: urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)
timeFrame: 3 months
measure: Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research and Medicine, Holstebro Regional Hospital
Study officials:
References: