Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome
Primary Purpose
Obstructive Sleep Apnea, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
CPAP device - REMstar Plus, Respironics, Murrysville, USA
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, risk factors, continuous positive airway pressure, insulin resistance, metabolic syndrome, compliance
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
Sites / Locations
- Medical Faculty, PJ Safarik University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I - compliant
Group 2-noncompliant
Arm Description
CPAP use for more than 4 hr/night
CPAP for less than 4 hr/night
Outcomes
Primary Outcome Measures
Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)
Secondary Outcome Measures
insulin sensitivity
Full Information
NCT ID
NCT00635674
First Posted
February 25, 2008
Last Updated
March 13, 2008
Sponsor
Pavol Jozef Safarik University
1. Study Identification
Unique Protocol Identification Number
NCT00635674
Brief Title
Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome
Official Title
Effects of CPAP on Cardiovascular Risk Profile in Patients With Severe Obstructive Sleep Apnea and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pavol Jozef Safarik University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Metabolic Syndrome
Keywords
sleep apnea, risk factors, continuous positive airway pressure, insulin resistance, metabolic syndrome, compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I - compliant
Arm Type
Experimental
Arm Description
CPAP use for more than 4 hr/night
Arm Title
Group 2-noncompliant
Arm Type
Active Comparator
Arm Description
CPAP for less than 4 hr/night
Intervention Type
Device
Intervention Name(s)
CPAP device - REMstar Plus, Respironics, Murrysville, USA
Other Intervention Name(s)
REMstar Plus, Respironics, Murrysville, Pennsylvania, USA
Intervention Description
continuous positive airway pressure device with heated humidification
Primary Outcome Measure Information:
Title
Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)
Time Frame
8 weeks therapy with Continuous positive airway pressure
Secondary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruzena Tkacova, MD,PhD
Organizational Affiliation
Head, Department of Respiratory Medicine, Medical Faculty PJ SAfarik University and L Pasteur Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Faculty, PJ Safarik University
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18625666
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome
We'll reach out to this number within 24 hrs