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Effect of Obstructive Sleep Apnea on Central Blood Pressure and Kidney and Endothelial Function (OSA-AKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947479
Recruitment Status : Unknown
Verified July 2009 by Medical Universtity of Lodz.
Recruitment status was:  Recruiting
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Medical Universtity of Lodz

Brief Summary:
Obstructive sleep apnea (OSA) is a frequently underdiagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension myocardial infarction or stroke and it has been documented that blood pressure rises in a very consistent fashion during apneic episodes. The incidence of the episodes of apnea during sleep causes repeated subclinical acute kidney injuries (AKI) contributing to the development of CKD. One of the mechanisms responsible for AKI might be endothelial injury followed by an increase of central aortic pressure.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Acute Kidney Failure Chronic Kidney Disease Other: continuous positive airway pressure (CPAP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Correction of Obstructive Sleep Apnea With Positive Airway Pressure on Central Blood Pressure and Kidney and Endothelial Function
Study Start Date : February 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
continuous positive airway pressure (CPAP)
CPAP will be applied in all patients
Other: continuous positive airway pressure (CPAP)
After being qualified into the study according to the aforementioned inclusion criteria and after giving an informed consent the polysomnography will be performed in all patients during night rest.In all patients eligible to sleep apnea treatment according to apnea/hypopnea index (AHI, number of apneic/hypopneic episodes per 1 h of effective sleep) from diagnostic polysomnography, CPAP treatment will be introduced under polysomnographic surveillance and the same panel of clinical and biochemical parameters will be evaluated.
Other Name: Epworth sleepiness scale (ESS)




Primary Outcome Measures :
  1. presence of acute kidney injury [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males with high risk of obstructive sleep apnea syndrome as clinically assessed by coincidence of typical symptoms (e.g. daily somnolence, witnessed apnea, non-refreshing sleep), obesity and high score on Epworth sleepiness scale (ESS) with age range from 18 to 70 years
  2. Glomerular filtration rate (MDRD formula-based) > 60 ml/min
  3. Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines.

Exclusion Criteria:

  1. Mental illness
  2. Proteinuria >2 g/24h
  3. Acute and chronic inflammation
  4. Heart failure III or IV grade
  5. Uncontrolled diabetes mellitus
  6. Severe lipid disturbances (triglyceride and/or total cholesterol concentration > 300 mg/dl)
  7. Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics
  8. Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system

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): NCT00947479


Contacts
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Contact: Michał Nowicki, MD, PhD (+48)426776709 nefro@wp.pl
Contact: Anna Zawiasa-Bryszewska, MD (+48)426776709 ania_zawiasa@go2.pl

Locations
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Poland
Medical University Recruiting
Lodz, Lodzkie, Poland, 90-153
Contact: Anna Zawiasa-Bryszewska, MD    (+48)426776709    ania_zawiasa@go2.pl   
Contact: Małgorzata Kołodziejska, MD    (+48)426776709    niedobrus@o2.pl   
Sub-Investigator: Piotr Białasiewicz, MD         
Principal Investigator: Dariusz Nowak, MD, PhD         
Sub-Investigator: Maciej Banasiak, MD         
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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Study Chair: Michał Nowicki, MD, PhD Medical University of Lodz, Poland
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Responsible Party: Professor Michał Nowicki, Department of Nephrology, Hypertension and Kidney Transplantation
ClinicalTrials.gov Identifier: NCT00947479    
Other Study ID Numbers: UMLodz OSA-AKI
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009
Keywords provided by Medical Universtity of Lodz:
obstructive sleep apnea
pulse-wave velocity,
acute kidney injury
biomarkers of acute kidney injury
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Acute Kidney Injury
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Urologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases