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Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea (NOSI)

Primary Purpose

Chronic Kidney Disease, Obstructive Sleep Apnea

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

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
  • Obstructive sleep apnea, AHI> 15 (moderate to severe)
  • both men and women
  • 18-80 years

Exclusion Criteria:

  • lack of desire to participate
  • malignant disease
  • Abuse of drugs or alcohol
  • pregnant and lactating
  • incompensated heart failure
  • atrial fibrillation
  • liver disease (alanine aminotransferase> 200)
  • Severe chronic obstructive lung disease (Forced expiratory volume in 1 second <50% predicted)

Sites / Locations

  • Medicinsk Forskning

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP treatment

Arm Description

Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment

Outcomes

Primary Outcome Measures

decrease in systolic night time blood pressure
The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.

Secondary Outcome Measures

difference in systolic blood pressure at night by central blood pressure monitoring
The difference in systolic blood pressure at night by central 24-h blood pressure monitoring before and after 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency
systolic and diastolic blood pressure throughout the day
The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in night time between measurements with peripheral 24-h blood pressure and central 24-h blood pressure before and after 3 months of treatment with CPAP.
correlation between blood pressure, OSA and kidney function
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 measured by estimates glomerular filtration rate, on the other
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. Difference in these before and after 3 months of treatment
quality af life
difference in the quality of life before and after 3 months of CPAP treatment

Full Information

First Posted
September 23, 2013
Last Updated
October 8, 2014
Sponsor
Erling Bjerregaard Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT01951248
Brief Title
Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea
Acronym
NOSI
Official Title
Central and Peripheral 24-h Blood Pressure Measurements in Patients With Chronic Renal Failure and Obstructive Sleep Apnea Before and After Treatment With CPAP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 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 investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water. Hypothesis: Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep. Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP. The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP. 4 Quality of life is improved during treatment with CPAP.
Detailed Description
Approximately 30 patients with chronic kidney disease and obstructive sleep apnea in moderate to severe degree is examined with central and peripheral 24-h blood pressure monitoring, 1 night home polygraphy to determine the degree of sleep apnea, blood and urine samples to determine levels of u-AQP2, u-ENAC, plasma renin concentration (PRC), s-angiotensin II (p-angII), p-aldosterone, p-vasopressin (p-avp) and p-endothelin, before the start treatment with CPAP for sleep apnea. After 3 month of treatment all the above described is repeated to determine effects of CPAP treatment on blood pressure levels during the day, changes i apnea hypopnea index (AHI) and the kidneys treatment of salt and water.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Obstructive Sleep Apnea
Keywords
chronic kidney disease, obstructive sleep apnea, 24-h blood pressure, central blood pressure, peripheral blood pressure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment
Intervention Type
Device
Intervention Name(s)
CPAP - continuous airway pressure
Other Intervention Name(s)
S9 AutoSet from ResMed/Maribo Medico, or, REMstar Auto A-Flex from Phillips/Respirsonics
Intervention Description
3 months of treatment with CPAP treatment
Primary Outcome Measure Information:
Title
decrease in systolic night time blood pressure
Description
The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
difference in systolic blood pressure at night by central blood pressure monitoring
Description
The difference in systolic blood pressure at night by central 24-h blood pressure monitoring before and after 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency
Time Frame
3 months
Title
systolic and diastolic blood pressure throughout the day
Description
The difference in systolic blood pressure and diastolic blood pressure throughout the day, in the daytime and in night time between measurements with peripheral 24-h blood pressure and central 24-h blood pressure before and after 3 months of treatment with CPAP.
Time Frame
3 months
Title
correlation between blood pressure, OSA and kidney function
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 measured by estimates glomerular filtration rate, on the other
Time Frame
3 months
Title
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.
Description
U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. Difference in these before and after 3 months of treatment
Time Frame
3 months
Title
quality af life
Description
difference in the quality of life before and after 3 months of CPAP treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2 Obstructive sleep apnea, AHI> 15 (moderate to severe) both men and women 18-80 years Exclusion Criteria: lack of desire to participate malignant disease Abuse of drugs or alcohol pregnant and lactating incompensated heart failure atrial fibrillation liver disease (alanine aminotransferase> 200) Severe chronic obstructive lung disease (Forced expiratory volume in 1 second <50% predicted)
Facility Information:
Facility Name
Medicinsk Forskning
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

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Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea

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