Skip to main content
OpenTrials
Completed

NCT Number: NCT00635674

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP device - REMstar Plus, Respironics, Murrysville, USA

Device

continuous positive airway pressure device with heated humidification

Other names: REMstar Plus, Respironics, Murrysville, Pennsylvania, USA

Primary outcomes

  1. Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)

    Time frame: 8 weeks therapy with Continuous positive airway pressure

Secondary outcomes

  1. insulin sensitivity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Pavol Jozef Safarik University

Other

Registry information

Official study title

Effects of CPAP on Cardiovascular Risk Profile in Patients With Severe Obstructive Sleep Apnea and Metabolic Syndrome

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.