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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635674
• Other study ID #: OSAMSCPAP
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: March 13, 2008
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2008
• Source: Pavol Jozef Safarik University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome
• Metabolic Syndrome X
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• CPAP device - REMstar Plus, Respironics, Murrysville, USA
continuous positive airway pressure device with heated humidification

Locations

Country	Name	City	State
Slovakia	Medical Faculty, PJ Safarik University	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Pavol Jozef Safarik University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)		8 weeks therapy with Continuous positive airway pressure	No
Secondary	insulin sensitivity		8 weeks	No