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

Hypertension Clinical Trial

— HOSI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02078778
• Other study ID #: BGH-4-2013
• Secondary ID: M-2013-304-13
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2014
• Last updated: January 30, 2015
• Start date: February 2014
• Est. completion date: March 2017

Study information

• Verified date: January 2015
• 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
3 months of CPAP treatment

Locations

Country	Name	City	State
Denmark	Department of Medical Research and Medicine, Holstebro Regional Hospital	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	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life	Changes in the quality of life before and after treatment of OSA with CPAP.	3 months	No