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

NCT00635674 | Completed

• 1 other identifier: OSAMSCPAP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Metabolic Syndrome

Keywords

sleep apnea; risk factors; continuous positive airway pressure; insulin resistance; metabolic syndrome; compliance

Outcome Measures

Primary Outcomes (1)

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

  8 weeks therapy with Continuous positive airway pressure

Secondary Outcomes (1)

• insulin sensitivity

  8 weeks

Study Arms (2)

Group I - compliant

EXPERIMENTAL

CPAP use for more than 4 hr/night

Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA

Group 2-noncompliant

ACTIVE COMPARATOR

CPAP for less than 4 hr/night

Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA

Interventions

CPAP device - REMstar Plus, Respironics, Murrysville, USA DEVICE

continuous positive airway pressure device with heated humidification

Also known as: REMstar Plus, Respironics, Murrysville, Pennsylvania, USA

Group 2-noncompliant; Group I - compliant

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead

Study Sites (1)

Medical Faculty, PJ Safarik University

Košice, Slovakia, 041 90, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 18625666 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Metabolic Syndrome; Sleep Apnea Syndromes; Insulin Resistance; Patient Compliance

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ruzena Tkacova, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 14, 2008

Record last verified: 2008-03

Locations

SL (1)