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

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.

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Recruiting
    • Department of Medical Research and Medicine, Holstebro Regional Hospital
    • Contact: Bodil Gade Hornstrup, MD; Phone Number: +4578436587; Email: bodil.hornstrup@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.	Device: CPAP; 3 months of CPAP treatment; Other Names: or; S9 AutoSet frem ResMed/MAribo Medico; REMstar Auto A-Flex frem Phillips/Respirsonics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in systolic peripheral BP at night	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference i central systolic BP	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.	3 months
Difference i BP throughout the day	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.	3 months
Correlation between degree of OSA and kidney function on effect of treatment	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.	3 months
urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)	Changes in U-AQP2 and u-ENaC in 24-h urine samples before and after 3 month of treatment.	3 months
Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).	Changes in PRC, p-AngII, p-Aldo. P-AVP and p-endothelin in blood samples before and after 3 month of treatment.	3 months
Quality of life	Changes in the quality of life before and after treatment of OSA with CPAP.	3 months

Collaborators and Investigators

• Sponsor: Erling Bjerregaard Pedersen

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 1, 2014
• First Submitted That Met QC Criteria: March 1, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension; Obstructive sleep apnea; Continuous airway pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea
• Other Study ID Numbers: BGH-4-2013; M-2013-304-13 (Other Identifier: The Regional Committee of Health Research Ethics)