Obstructive Sleep Apnea Clinical Trial
— OSA-AKIOfficial title:
Effect of Correction of Obstructive Sleep Apnea With Positive Airway Pressure on Central Blood Pressure and Kidney and Endothelial Function
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Poland | Medical University | Lodz | Lodzkie |
Lead Sponsor | Collaborator |
---|---|
Medical Universtity of Lodz |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence of acute kidney injury | one year | Yes |
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