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Trial record 51 of 1620 for:    Slovakia

Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00635674
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
Sponsor:
Information provided by:
Pavol Jozef Safarik University

Brief Summary:

The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic inflammation, and oxidative stress in previous studies.

We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Metabolic Syndrome Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA Not Applicable

Detailed Description:

Patients with obstructive sleep apnea (OSA) are at increased risk of atherosclerotic morbidity and mortality.OSA is associated with the development and/or worsening of arterial hypertension, a traditional risk factor of atherosclerosis.Moreover, OSA has been linked to novel factors related to atherogenesis - metabolic syndrome,systemic inflammation,6 and oxidative stress.

Numerous studies have selectively examined the effects of continuous positive airway pressure (CPAP) ventilation, the primary treatment for OSA, on the traditional and novel risk factors of atherosclerosis. A recent metaanalysis of 16 randomized trials indicated that CPAP decreases blood pressure in patients with OSA.9 Furthermore, reductions in serum total cholesterol, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6 and IL-8 were demonstrated after effective CPAP therapy.In addition, CPAP was shown to reduce systemic oxidative stress.Improvements in insulin sensitivity have been reported in some,but not in all studies. Importantly, substantial evidence links the effects of CPAP to compliance with this treatment.

Most observational studies examined the effects of CPAP across a broad-range of OSA severity, and have included patients with and without the metabolic syndrome. Up to now, no study analyzed the effects of CPAP on glucose and lipid metabolism, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk within the same cohort of subjects with severe OSA and concurrent metabolic syndrome. Importantly, the metabolic syndrome exacerbates CVD risk over and above that attributable to OSA alone. Therefore, reduction of CVD risk in patients with OSA and concurrent metabolic syndrome is of paramount importance.

The primary purpose of the present study was to determine, in patients with severe OSA and metabolic syndrome compliant to CPAP, the effects of 8-weeks therapy on the glucose and lipid profile, systemic inflammation, oxidative stress, and on the global CVD risk. The secondary goal was to analyze factors related to compliance with CPAP.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of CPAP on Cardiovascular Risk Profile in Patients With Severe Obstructive Sleep Apnea and Metabolic Syndrome
Study Start Date : February 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I - compliant
CPAP use for more than 4 hr/night
Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA
continuous positive airway pressure device with heated humidification
Other Name: REMstar Plus, Respironics, Murrysville, Pennsylvania, USA

Active Comparator: Group 2-noncompliant
CPAP for less than 4 hr/night
Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA
continuous positive airway pressure device with heated humidification
Other Name: REMstar Plus, Respironics, Murrysville, Pennsylvania, USA




Primary Outcome Measures :
  1. Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm) [ Time Frame: 8 weeks therapy with Continuous positive airway pressure ]

Secondary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe OSA (more than 30 obstructive apneas or hypopneas per hour of sleep and excessive daytime sleepiness)
  • metabolic syndrome

Exclusion Criteria:

  • endocrine or metabolic disorders other than metabolic syndrome
  • history of myocardial infarction, angina or stroke
  • inflammatory or other chronic disease
  • respiratory disorder other than OSA
  • neurological lesions
  • regular use of sedative medication or alcohol

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): NCT00635674


Locations
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Slovakia
Medical Faculty, PJ Safarik University
Kosice, Slovakia, 041 90
Sponsors and Collaborators
Pavol Jozef Safarik University
Investigators
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Principal Investigator: Ruzena Tkacova, MD,PhD Head, Department of Respiratory Medicine, Medical Faculty PJ SAfarik University and L Pasteur Teaching Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ruzena Tkacova, MD, PhD, Professor of Medicine, Medical Faculty, PJ Safarik University and L. Pasteur Teaching Hospital
ClinicalTrials.gov Identifier: NCT00635674     History of Changes
Other Study ID Numbers: OSAMSCPAP
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008

Keywords provided by Pavol Jozef Safarik University:
sleep apnea
risk factors
continuous positive airway pressure
insulin resistance
metabolic syndrome
compliance

Additional relevant MeSH terms:
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Syndrome
Apnea
Sleep Apnea Syndromes
Metabolic Syndrome
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases