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

NCT ID: NCT00635674

Last Updated: 2008-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-02-29

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.

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.

Conditions

Obstructive Sleep Apnea; Metabolic Syndrome

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I - compliant

CPAP use for more than 4 hr/night

Group Type: EXPERIMENTAL

CPAP device - REMstar Plus, Respironics, Murrysville, USA

Intervention Type: DEVICE

continuous positive airway pressure device with heated humidification

Group 2-noncompliant

CPAP for less than 4 hr/night

Group Type: ACTIVE_COMPARATOR

CPAP device - REMstar Plus, Respironics, Murrysville, USA

Intervention Type: DEVICE

continuous positive airway pressure device with heated humidification

Interventions

CPAP device - REMstar Plus, Respironics, Murrysville, USA

continuous positive airway pressure device with heated humidification

Intervention Type: DEVICE

Other Intervention Names

REMstar Plus, Respironics, Murrysville, Pennsylvania, USA

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pavol Jozef Safarik University

OTHER

Sponsor Role: lead

Responsible Party

Medical Faculty, PJ Safarik University and L. Pasteur Teaching Hospital

Principal Investigators

Ruzena Tkacova, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Head, Department of Respiratory Medicine, Medical Faculty PJ SAfarik University and L Pasteur Teaching Hospital

Locations

Medical Faculty, PJ Safarik University

Košice, Slovakia, Slovakia

Countries

Slovakia

References

Dorkova Z, Petrasova D, Molcanyiova A, Popovnakova M, Tkacova R. Effects of continuous positive airway pressure on cardiovascular risk profile in patients with severe obstructive sleep apnea and metabolic syndrome. Chest. 2008 Oct;134(4):686-692. doi: 10.1378/chest.08-0556. Epub 2008 Jul 14.

Reference Type: DERIVED

PMID: 18625666 (View on PubMed)

Other Identifiers

OSAMSCPAP

Identifier Type: -

Identifier Source: org_study_id