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

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ClinicalTrials.gov Identifier: NCT01951248
Recruitment Status : Unknown
Verified October 2014 by Erling Bjerregaard Pedersen, Regional Hospital Holstebro.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2013
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

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:

  1. 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.
  2. Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
  3. 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Obstructive Sleep Apnea Device: CPAP - continuous airway pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPAP treatment
Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment
Device: CPAP - continuous airway pressure
3 months of treatment with CPAP treatment
Other Names:
  • S9 AutoSet from ResMed/Maribo Medico
  • or
  • REMstar Auto A-Flex from Phillips/Respirsonics




Primary Outcome Measures :
  1. decrease in systolic night time blood pressure [ Time Frame: 3 months ]
    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 :
  1. difference in systolic blood pressure at night by central blood pressure monitoring [ Time Frame: 3 months ]
    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

  2. systolic and diastolic blood pressure throughout the day [ Time Frame: 3 months ]
    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.

  3. correlation between blood pressure, OSA and kidney function [ Time Frame: 3 months ]
    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

  4. U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial. [ Time Frame: 3 months ]
    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

  5. quality af life [ Time Frame: 3 months ]
    difference in the quality of life before and after 3 months of CPAP treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951248


Locations
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Denmark
Medicinsk Forskning
Holstebro, Denmark, 7500
Sponsors and Collaborators
Erling Bjerregaard Pedersen

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Responsible Party: Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01951248    
Other Study ID Numbers: BGH-3-2013
M-2013-285-13 ( Other Identifier: The Regional Commitww of Health Research Ethics )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
chronic kidney disease
obstructive sleep apnea
24-h blood pressure
central blood pressure
peripheral blood pressure
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Urologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Renal Insufficiency