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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Medical Universtity of Lodz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00947479
First received: July 27, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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 Intervention
Obstructive Sleep Apnea
Acute Kidney Failure
Chronic Kidney Disease
 Other: continuous positive airway pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • presence of acute kidney injury [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947479

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

Locations
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
Study Chair: Michał Nowicki, MD, PhD Medical University of Lodz, Poland
  More Information

No publications provided

Responsible Party: Professor Michał Nowicki, Department of Nephrology, Hypertension and Kidney Transplantation
ClinicalTrials.gov Identifier: NCT00947479     History of Changes
Other Study ID Numbers: UMLodz OSA-AKI
Study First Received: July 27, 2009
Last Updated: July 27, 2009
Health Authority: Poland: Ethics Committee

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:
Apnea
Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Sleep Apnea Syndromes
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Sleep Apnea, Obstructive
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Urologic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013