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

Primary Purpose

Hypertension, Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CPAP
Sponsored by
Erling Bjerregaard Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Continuous airway pressure, Hypertension, Obstructive sleep apnea

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medical Research and Medicine, Holstebro Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Quality of life
Changes in the quality of life before and after treatment of OSA with CPAP.

Full Information

First Posted
March 1, 2014
Last Updated
January 30, 2015
Sponsor
Erling Bjerregaard Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT02078778
Brief Title
Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erling Bjerregaard Pedersen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obstructive Sleep Apnea
Keywords
Continuous airway pressure, Hypertension, Obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
S9 AutoSet frem ResMed/MAribo Medico, or, REMstar Auto A-Flex frem Phillips/Respirsonics
Intervention Description
3 months of CPAP treatment
Primary Outcome Measure Information:
Title
difference in systolic peripheral BP at night
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference i central systolic BP
Description
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.
Time Frame
3 months
Title
Difference i BP throughout the day
Description
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.
Time Frame
3 months
Title
Correlation between degree of OSA and kidney function on effect of treatment
Description
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.
Time Frame
3 months
Title
urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)
Description
Changes in U-AQP2 and u-ENaC in 24-h urine samples before and after 3 month of treatment.
Time Frame
3 months
Title
Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).
Description
Changes in PRC, p-AngII, p-Aldo. P-AVP and p-endothelin in blood samples before and after 3 month of treatment.
Time Frame
3 months
Title
Quality of life
Description
Changes in the quality of life before and after treatment of OSA with CPAP.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Medical Research and Medicine, Holstebro Regional Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bodil Gade Hornstrup, MD
Phone
+4578436587
Email
bodil.hornstrup@rm.dk

12. IPD Sharing Statement

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

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