Effect of Obstructive Sleep Apnea on Central Blood Pressure and Kidney and Endothelial Function

NCT00947479 | Unknown DMC

• 1 other identifier: UMLodz OSA-AKI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Acute Kidney Failure; Chronic Kidney Disease

Keywords

obstructive sleep apnea; pulse-wave velocity,; acute kidney injury; biomarkers of acute kidney injury

Outcome Measures

Primary Outcomes (1)

• presence of acute kidney injury

  one year

Study Arms (1)

continuous positive airway pressure (CPAP)

OTHER

CPAP will be applied in all patients

Other: continuous positive airway pressure (CPAP)

Interventions

continuous positive airway pressure (CPAP) OTHER

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.

Also known as: Epworth sleepiness scale (ESS)

continuous positive airway pressure (CPAP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Glomerular filtration rate (MDRD formula-based) \> 60 ml/min
• Arterial hypertension diagnosed according to the European Society of Hypertension 2007 Guidelines.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University

Lodz, Łódź Voivodeship, 90-153, Poland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Michał Nowicki, MD, PhD

  Medical University of Lodz, Poland

  STUDY CHAIR

Central Study Contacts

Michał Nowicki, MD, PhD

CONTACT

(+48)426776709; nefro@wp.pl

Anna Zawiasa-Bryszewska, MD

CONTACT

(+48)426776709; ania_zawiasa@go2.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 28, 2009

Record last verified: 2009-07

Locations

PL (1)